{
  "name": "EU and Swiss life sciences and ICT regulatory tracker",
  "description": "This dataset gives dated milestones and official-text links for the EU and Swiss instruments governing medical devices, in vitro diagnostics, medicinal products, clinical research, data protection, cybersecurity and AI, and pairs each EU instrument with its Swiss counterpart where one exists.",
  "url": "https://gawel.ch/regulatory-tracker/",
  "publisher": "Rechtsanwalt Dr. iur. Claus Gawel, LLM",
  "license": "https://gawel.ch/legal-notice/",
  "inLanguage": "en",
  "lastReviewed": "2026-09-24",
  "method": "Each milestone is checked against the official text its source link names, and each instrument against the consolidated version where an amending act moves its dates. The source on a milestone is the document it was read from, not a summary of it. The whole set was last reviewed on the date in lastReviewed. Dates are subject to change and this is a reference, not legal advice.",
  "counts": {
    "instruments": 41,
    "milestones": 131
  },
  "distributions": {
    "json": "https://gawel.ch/regulatory-tracker.json",
    "calendar": "https://gawel.ch/regulatory-tracker.ics"
  },
  "instruments": [
    {
      "id": "mdr",
      "url": "https://gawel.ch/regulatory-tracker/#reg-mdr",
      "shortName": "MDR",
      "fullName": "Medical Device Regulation",
      "citation": "Regulation (EU) 2017/745",
      "jurisdiction": "EU",
      "domain": "medtech",
      "status": "in-force",
      "summary": "EU framework governing the placing on the market and conformity of medical devices. A targeted MDR/IVDR simplification revision (COM(2025) 1023) is before Parliament and Council. The legacy-device dates below, marked conditional, apply only to devices that meet the conditions of Art. 120(3c) MDR as amended by Reg (EU) 2023/607.",
      "pairId": "medical-devices",
      "officialText": {
        "name": "Medical Device Regulation",
        "url": "https://eur-lex.europa.eu/eli/reg/2017/745/2026-07-19"
      },
      "relatedAnalysis": [
        {
          "title": "EU MDR Compliance for Swiss MedTech: The Dual-Track Reality",
          "url": "https://gawel.ch/insights/15-eu-mdr-compliance/"
        },
        {
          "title": "EU Authorized Representatives for Swiss Manufacturers Under the MDR and IVDR",
          "url": "https://gawel.ch/insights/05-swiss-authorized-representative-mdr/"
        },
        {
          "title": "Clinical Evidence for SaMD: What Swiss and EU Regulators Actually Expect",
          "url": "https://gawel.ch/insights/11-samd-clinical-evidence/"
        },
        {
          "title": "Post-Market Surveillance for SaMD: When Software Keeps Changing",
          "url": "https://gawel.ch/insights/12-samd-post-market-surveillance/"
        }
      ],
      "milestones": [
        {
          "date": "2017-04-05",
          "label": "Signed by Parliament and Council",
          "kind": "enacted",
          "source": "https://eur-lex.europa.eu/eli/reg/2017/745/oj"
        },
        {
          "date": "2021-05-26",
          "label": "Date of application",
          "kind": "applied",
          "source": "https://eur-lex.europa.eu/eli/reg/2020/561/oj"
        },
        {
          "date": "2025-12-16",
          "label": "Targeted MDR/IVDR simplification proposed (COM(2025) 1023)",
          "kind": "proposed",
          "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52025PC1023"
        },
        {
          "date": "2026-05-28",
          "label": "First four modules of the European database on medical devices (EUDAMED) mandatory (Reg (EU) 2024/1860)",
          "kind": "applied",
          "source": "https://eur-lex.europa.eu/eli/dec/2025/2371/oj"
        },
        {
          "date": "2027-12-31",
          "label": "Legacy transition ends for class III and class IIb implantable devices, except listed IIb implants such as screws and plates (conditional)",
          "kind": "deadline",
          "source": "https://eur-lex.europa.eu/eli/reg/2023/607/oj"
        },
        {
          "date": "2028-12-31",
          "label": "Legacy transition ends for other class IIb, class IIa, Is and Im devices, and for self-declared devices that now need a notified body (conditional)",
          "kind": "deadline",
          "source": "https://eur-lex.europa.eu/eli/reg/2023/607/oj"
        }
      ]
    },
    {
      "id": "mepv",
      "url": "https://gawel.ch/regulatory-tracker/#reg-mepv",
      "shortName": "MepV",
      "fullName": "Medizinprodukteverordnung",
      "citation": "SR 812.213",
      "jurisdiction": "CH",
      "domain": "medtech",
      "status": "in-force",
      "summary": "Swiss medical devices ordinance, aligned with but distinct from the EU MDR; legacy-device transition periods mirror Reg (EU) 2023/607 since November 2023.",
      "pairId": "medical-devices",
      "officialText": {
        "name": "Medizinprodukteverordnung",
        "url": "https://www.fedlex.admin.ch/eli/cc/2020/552/de"
      },
      "relatedAnalysis": [
        {
          "title": "Swiss MedTech Export Without the MRA: What Third-Country Status Requires",
          "url": "https://gawel.ch/insights/21-swiss-medtech-export/"
        }
      ],
      "milestones": [
        {
          "date": "2020-07-01",
          "label": "Adopted by the Federal Council",
          "kind": "enacted",
          "source": "https://www.fedlex.admin.ch/eli/oc/2020/552/de"
        },
        {
          "date": "2021-05-26",
          "label": "Entry into force (revised)",
          "kind": "applied",
          "source": "https://www.fedlex.admin.ch/eli/oc/2020/552/de"
        },
        {
          "date": "2023-11-01",
          "label": "Transition-period alignment with Reg (EU) 2023/607 in force",
          "kind": "applied",
          "source": "https://www.fedlex.admin.ch/eli/oc/2023/576/de"
        }
      ]
    },
    {
      "id": "bilaterale-iii",
      "url": "https://gawel.ch/regulatory-tracker/#reg-bilaterale-iii",
      "shortName": "Bilaterale III",
      "fullName": "Bilaterale III package (updated Mutual Recognition Agreement)",
      "citation": "BBl 2026 615 (Federal Council dispatch, Geschäft 26.023); signed 2 March 2026, ratification pending",
      "jurisdiction": "CH",
      "domain": "medtech",
      "status": "upcoming",
      "summary": "Signed treaty package updating the bilateral agreements between Switzerland and the EU. Its institutional protocol obliges both sides to incorporate EU acts within the scope of the Mutual Recognition Agreement (MRA) into its Annex 1 as soon as possible, by decision of the Joint Committee. The medical-devices chapter is to be updated that way once the package is in force; Switzerland remains a third country under the MDR and IVDR at least until that Joint Committee decision takes effect.",
      "pairId": "bilaterals-mra",
      "officialText": {
        "name": "Bilaterale III package (updated Mutual Recognition Agreement)",
        "url": "https://www.fedlex.admin.ch/eli/fga/2026/615/de"
      },
      "relatedAnalysis": [
        {
          "title": "Swiss MedTech Export Without the MRA: What Third-Country Status Requires",
          "url": "https://gawel.ch/insights/21-swiss-medtech-export/"
        }
      ],
      "milestones": [
        {
          "date": "2026-03-02",
          "label": "Package signed",
          "kind": "procedural",
          "source": "https://www.fedlex.admin.ch/eli/fga/2026/615/de"
        },
        {
          "date": "2026-03-13",
          "label": "Federal Council dispatch (Botschaft) adopted",
          "kind": "proposed",
          "source": "https://www.fedlex.admin.ch/eli/fga/2026/615/de"
        }
      ]
    },
    {
      "id": "ivdr",
      "url": "https://gawel.ch/regulatory-tracker/#reg-ivdr",
      "shortName": "IVDR",
      "fullName": "In Vitro Diagnostic Regulation",
      "citation": "Regulation (EU) 2017/746",
      "jurisdiction": "EU",
      "domain": "ivd",
      "status": "phasing-in",
      "summary": "EU framework for in vitro diagnostic medical devices. Transitional periods restructured by Regulation (EU) 2024/1860; a targeted MDR/IVDR simplification revision (COM(2025) 1023) is before Parliament and Council. The legacy-device dates below, marked conditional, apply only to devices that meet the conditions of Art. 110(3c) IVDR as amended by Reg (EU) 2024/1860.",
      "pairId": "ivd",
      "officialText": {
        "name": "In Vitro Diagnostic Regulation",
        "url": "https://eur-lex.europa.eu/eli/reg/2017/746/2025-01-10"
      },
      "relatedAnalysis": [
        {
          "title": "Software as a Medical Device (SaMD): Classification Pitfalls in Switzerland and the EU",
          "url": "https://gawel.ch/insights/07-samd-classification-pitfalls/"
        }
      ],
      "milestones": [
        {
          "date": "2017-04-05",
          "label": "Signed by Parliament and Council",
          "kind": "enacted",
          "source": "https://eur-lex.europa.eu/eli/reg/2017/746/oj"
        },
        {
          "date": "2022-05-26",
          "label": "Date of application",
          "kind": "applied",
          "source": "https://eur-lex.europa.eu/eli/reg/2017/746/oj"
        },
        {
          "date": "2025-05-26",
          "label": "Deadline to have a quality management system (QMS) under Art. 10(8) IVDR in place, a condition of the extended transition",
          "kind": "deadline",
          "source": "https://eur-lex.europa.eu/eli/reg/2024/1860/oj"
        },
        {
          "date": "2025-12-16",
          "label": "Targeted MDR/IVDR simplification proposed (COM(2025) 1023)",
          "kind": "proposed",
          "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52025PC1023"
        },
        {
          "date": "2027-12-31",
          "label": "Legacy transition ends for all Directive-certified devices and for self-declared class D devices (conditional)",
          "kind": "deadline",
          "source": "https://eur-lex.europa.eu/eli/reg/2024/1860/oj"
        },
        {
          "date": "2028-12-31",
          "label": "Legacy transition ends for self-declared class C devices (conditional)",
          "kind": "deadline",
          "source": "https://eur-lex.europa.eu/eli/reg/2024/1860/oj"
        },
        {
          "date": "2029-12-31",
          "label": "Legacy transition ends for self-declared class B and sterile class A devices (conditional)",
          "kind": "deadline",
          "source": "https://eur-lex.europa.eu/eli/reg/2024/1860/oj"
        },
        {
          "date": "2030-12-31",
          "label": "Health institutions must justify each in-house device by showing that no equivalent device on the market meets the target patient group's needs (Art. 5(5)(d) IVDR, deferred by Reg (EU) 2024/1860)",
          "kind": "deadline",
          "source": "https://eur-lex.europa.eu/eli/reg/2024/1860/oj"
        }
      ]
    },
    {
      "id": "ivdv",
      "url": "https://gawel.ch/regulatory-tracker/#reg-ivdv",
      "shortName": "IvDV",
      "fullName": "Verordnung über In-vitro-Diagnostika",
      "citation": "SR 812.219",
      "jurisdiction": "CH",
      "domain": "ivd",
      "status": "phasing-in",
      "summary": "Swiss in vitro diagnostics ordinance mirroring the EU IVDR. The January 2025 amendment mirrors the transition extensions of Reg (EU) 2024/1860 and defers to 31 December 2030 the duty of health institutions to justify each in-house device by showing that no equivalent device on the market meets the need.",
      "pairId": "ivd",
      "officialText": {
        "name": "Verordnung über In-vitro-Diagnostika",
        "url": "https://www.fedlex.admin.ch/eli/cc/2022/291/de"
      },
      "milestones": [
        {
          "date": "2022-05-04",
          "label": "Adopted by the Federal Council",
          "kind": "enacted",
          "source": "https://www.fedlex.admin.ch/eli/oc/2022/291/de"
        },
        {
          "date": "2022-05-26",
          "label": "Entry into force",
          "kind": "applied",
          "source": "https://www.fedlex.admin.ch/eli/oc/2022/291/de"
        },
        {
          "date": "2025-01-01",
          "label": "Transition-alignment amendment in force (mirrors Reg (EU) 2024/1860)",
          "kind": "applied",
          "source": "https://www.fedlex.admin.ch/eli/oc/2024/741/de"
        },
        {
          "date": "2030-12-31",
          "label": "Health institutions must justify each in-house device by showing that no equivalent device on the market meets the target patient group's needs",
          "kind": "deadline",
          "source": "https://www.fedlex.admin.ch/eli/oc/2024/741/de"
        }
      ]
    },
    {
      "id": "gdpr",
      "url": "https://gawel.ch/regulatory-tracker/#reg-gdpr",
      "shortName": "GDPR",
      "fullName": "General Data Protection Regulation",
      "citation": "Regulation (EU) 2016/679",
      "jurisdiction": "EU",
      "domain": "data",
      "status": "in-force",
      "summary": "EU data protection regime for the processing of personal data. The Digital Omnibus (data) proposal of November 2025 (COM(2025) 837) would amend it; it is still before Parliament and Council and has not been adopted.",
      "pairId": "data-protection",
      "officialText": {
        "name": "General Data Protection Regulation",
        "url": "https://eur-lex.europa.eu/eli/reg/2016/679/oj"
      },
      "relatedAnalysis": [
        {
          "title": "Data Privacy in Clinical Trials: GDPR Meets DSG",
          "url": "https://gawel.ch/insights/03-gdpr-clinical-trials/"
        }
      ],
      "milestones": [
        {
          "date": "2016-04-27",
          "label": "Signed by Parliament and Council",
          "kind": "enacted",
          "source": "https://eur-lex.europa.eu/eli/reg/2016/679/oj"
        },
        {
          "date": "2018-05-25",
          "label": "Date of application",
          "kind": "applied",
          "source": "https://eur-lex.europa.eu/eli/reg/2016/679/oj"
        },
        {
          "date": "2025-11-19",
          "label": "Digital Omnibus (data) amendment proposed (COM(2025) 837)",
          "kind": "proposed",
          "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52025PC0837"
        }
      ]
    },
    {
      "id": "dsg",
      "url": "https://gawel.ch/regulatory-tracker/#reg-dsg",
      "shortName": "DSG",
      "fullName": "Datenschutzgesetz",
      "citation": "SR 235.1",
      "jurisdiction": "CH",
      "domain": "data",
      "status": "in-force",
      "summary": "Swiss federal data protection act (revised).",
      "pairId": "data-protection",
      "officialText": {
        "name": "Datenschutzgesetz",
        "url": "https://www.fedlex.admin.ch/eli/cc/2022/491/de"
      },
      "relatedAnalysis": [
        {
          "title": "Data Privacy in Clinical Trials: GDPR Meets DSG",
          "url": "https://gawel.ch/insights/03-gdpr-clinical-trials/"
        }
      ],
      "milestones": [
        {
          "date": "2020-09-25",
          "label": "Adopted by Parliament (final vote)",
          "kind": "enacted",
          "source": "https://www.fedlex.admin.ch/eli/oc/2022/491/de"
        },
        {
          "date": "2023-09-01",
          "label": "Revised act in force",
          "kind": "applied",
          "source": "https://www.fedlex.admin.ch/eli/oc/2022/491/de"
        }
      ]
    },
    {
      "id": "ehds",
      "url": "https://gawel.ch/regulatory-tracker/#reg-ehds",
      "shortName": "EHDS",
      "fullName": "European Health Data Space Regulation",
      "citation": "Regulation (EU) 2025/327",
      "jurisdiction": "EU",
      "domain": "data",
      "status": "upcoming",
      "summary": "EU framework for electronic health data: access and exchange for patient care, including across borders (primary use), and reuse for research, innovation and policy-making (secondary use), with obligations for manufacturers of electronic health record (EHR) systems.",
      "pairId": "health-data",
      "officialText": {
        "name": "European Health Data Space Regulation",
        "url": "https://eur-lex.europa.eu/eli/reg/2025/327/oj"
      },
      "milestones": [
        {
          "date": "2025-02-11",
          "label": "Signed by Parliament and Council",
          "kind": "enacted",
          "source": "https://eur-lex.europa.eu/eli/reg/2025/327/oj"
        },
        {
          "date": "2025-03-25",
          "label": "Entry into force",
          "kind": "applied",
          "source": "https://eur-lex.europa.eu/eli/reg/2025/327/oj"
        },
        {
          "date": "2027-03-26",
          "label": "General application; core implementing acts due",
          "kind": "deadline",
          "source": "https://eur-lex.europa.eu/eli/reg/2025/327/oj"
        },
        {
          "date": "2027-03-26",
          "label": "Member States name their digital health authorities, health data access bodies and national contact points, and notify their penalty rules (Art. 19, Art. 23, Art. 55, Art. 75 and Art. 99 EHDS)",
          "kind": "deadline",
          "source": "https://eur-lex.europa.eu/eli/reg/2025/327/oj"
        },
        {
          "date": "2029-03-26",
          "label": "Primary-use rules apply to the first priority data categories (patient summaries, electronic prescriptions and dispensations); secondary-use rules apply to most data categories",
          "kind": "deadline",
          "source": "https://eur-lex.europa.eu/eli/reg/2025/327/oj"
        },
        {
          "date": "2031-03-26",
          "label": "Primary-use rules extend to medical imaging studies, test results and discharge reports; secondary-use rules extend to the remaining data categories, including genomic data",
          "kind": "deadline",
          "source": "https://eur-lex.europa.eu/eli/reg/2025/327/oj"
        }
      ]
    },
    {
      "id": "epdg",
      "url": "https://gawel.ch/regulatory-tracker/#reg-epdg",
      "shortName": "EPDG",
      "fullName": "Bundesgesetz über das elektronische Patientendossier",
      "citation": "SR 816.1",
      "jurisdiction": "CH",
      "domain": "data",
      "status": "in-force",
      "summary": "Swiss electronic patient record act. A total revision, the EGDG (Bundesgesetz über das elektronische Gesundheitsdossier: an electronic health record with an opt-out model on a single federal platform), is before Parliament; the new system is planned to operate from around 2030.",
      "pairId": "health-data",
      "officialText": {
        "name": "Bundesgesetz über das elektronische Patientendossier",
        "url": "https://www.fedlex.admin.ch/eli/cc/2017/203/de"
      },
      "milestones": [
        {
          "date": "2015-06-19",
          "label": "Adopted by Parliament (final vote)",
          "kind": "enacted",
          "source": "https://www.fedlex.admin.ch/eli/oc/2017/203/de"
        },
        {
          "date": "2017-04-15",
          "label": "Entry into force",
          "kind": "applied",
          "source": "https://www.fedlex.admin.ch/eli/oc/2017/203/de"
        },
        {
          "date": "2025-11-05",
          "label": "Federal Council dispatch on the EGDG (total revision) adopted",
          "kind": "proposed",
          "source": "https://www.fedlex.admin.ch/eli/fga/2025/3398/de"
        }
      ]
    },
    {
      "id": "data-act",
      "url": "https://gawel.ch/regulatory-tracker/#reg-data-act",
      "shortName": "Data Act",
      "fullName": "Data Act",
      "citation": "Regulation (EU) 2023/2854",
      "jurisdiction": "EU",
      "domain": "data",
      "status": "phasing-in",
      "summary": "EU horizontal rules on access to connected-product data, business-to-business data sharing, and cloud switching.",
      "pairId": "data-act",
      "officialText": {
        "name": "Data Act",
        "url": "https://eur-lex.europa.eu/eli/reg/2023/2854/oj"
      },
      "relatedAnalysis": [
        {
          "title": "Cloud Service Contracts: Jurisdictional Complexity",
          "url": "https://gawel.ch/insights/17-cloud-contracts-jurisdiction/"
        }
      ],
      "milestones": [
        {
          "date": "2023-12-13",
          "label": "Signed by Parliament and Council",
          "kind": "enacted",
          "source": "https://eur-lex.europa.eu/eli/reg/2023/2854/oj"
        },
        {
          "date": "2024-01-11",
          "label": "Entry into force",
          "kind": "applied",
          "source": "https://eur-lex.europa.eu/eli/reg/2023/2854/oj"
        },
        {
          "date": "2025-09-12",
          "label": "Main obligations apply",
          "kind": "applied",
          "source": "https://eur-lex.europa.eu/eli/reg/2023/2854/oj"
        },
        {
          "date": "2026-09-12",
          "label": "Access-by-design duty for newly marketed connected products (Art. 3(1) Data Act)",
          "kind": "deadline",
          "source": "https://eur-lex.europa.eu/eli/reg/2023/2854/oj"
        },
        {
          "date": "2027-09-12",
          "label": "Unfair-terms rules extend to pre-existing long-term contracts",
          "kind": "deadline",
          "source": "https://eur-lex.europa.eu/eli/reg/2023/2854/oj"
        }
      ]
    },
    {
      "id": "nis2",
      "url": "https://gawel.ch/regulatory-tracker/#reg-nis2",
      "shortName": "NIS2",
      "fullName": "Directive on measures for a high common level of cybersecurity across the Union",
      "citation": "Directive (EU) 2022/2555",
      "jurisdiction": "EU",
      "domain": "cyber",
      "status": "phasing-in",
      "summary": "EU directive raising cybersecurity obligations for essential and important entities; technical requirements for digital-infrastructure entities specified by Implementing Regulation (EU) 2024/2690. Four Member States (Ireland, Spain, France and the Netherlands) were referred to the Court of Justice on 8 July 2026 over missing transposition (Commission press release IP/26/1499).",
      "pairId": "network-security",
      "officialText": {
        "name": "Directive on measures for a high common level of cybersecurity across the Union",
        "url": "https://eur-lex.europa.eu/eli/dir/2022/2555/oj"
      },
      "relatedAnalysis": [
        {
          "title": "NIS2 for Connected Medical Devices: Cybersecurity Requirements and Implications",
          "url": "https://gawel.ch/insights/19-nis2-medtech-cybersecurity/"
        }
      ],
      "milestones": [
        {
          "date": "2022-12-14",
          "label": "Signed by Parliament and Council",
          "kind": "enacted",
          "source": "https://eur-lex.europa.eu/eli/dir/2022/2555/oj"
        },
        {
          "date": "2024-10-17",
          "label": "Member-State transposition deadline",
          "kind": "deadline",
          "source": "https://eur-lex.europa.eu/eli/dir/2022/2555/oj"
        }
      ]
    },
    {
      "id": "isg",
      "url": "https://gawel.ch/regulatory-tracker/#reg-isg",
      "shortName": "ISG",
      "fullName": "Informationssicherheitsgesetz",
      "citation": "SR 128",
      "jurisdiction": "CH",
      "domain": "cyber",
      "status": "in-force",
      "summary": "Swiss information security act, including the duty of critical-infrastructure operators to report cyberattacks to the Federal Office for Cybersecurity (BACS) within 24 hours of discovery. Its staged entry into force was completed on 1 October 2025. The Federal Council intends to move this reporting duty into a separate cybersecurity act (Cybersicherheitsgesetz, CSG), which is also to set cybersecurity requirements for hardware and software products, oriented on the EU Cyber Resilience Act; a consultation draft is due by June 2027.",
      "pairId": "network-security",
      "officialText": {
        "name": "Informationssicherheitsgesetz",
        "url": "https://www.fedlex.admin.ch/eli/cc/2022/232/de"
      },
      "relatedAnalysis": [
        {
          "title": "Cybersecurity for SaMD: Meeting MDR and Beyond",
          "url": "https://gawel.ch/insights/18-samd-cybersecurity/"
        }
      ],
      "milestones": [
        {
          "date": "2020-12-18",
          "label": "Adopted by Parliament (final vote)",
          "kind": "enacted",
          "source": "https://www.fedlex.admin.ch/eli/oc/2022/232/de"
        },
        {
          "date": "2024-01-01",
          "label": "Entry into force (staged)",
          "kind": "applied",
          "source": "https://www.fedlex.admin.ch/eli/oc/2023/650/de"
        },
        {
          "date": "2025-04-01",
          "label": "Reporting duty in force: critical-infrastructure operators must report cyberattacks to the Federal Office for Cybersecurity (BACS) within 24 hours of discovery",
          "kind": "applied",
          "source": "https://www.fedlex.admin.ch/eli/oc/2025/173/de"
        },
        {
          "date": "2025-10-01",
          "label": "Reporting-duty sanctions in force",
          "kind": "applied",
          "source": "https://www.fedlex.admin.ch/eli/oc/2025/173/de"
        },
        {
          "date": "2026-09-25",
          "label": "Federal Council mandated a consultation draft, due by June 2027, for a separate cybersecurity act (Cybersicherheitsgesetz, CSG)",
          "kind": "procedural",
          "source": "https://www.admin.ch/de/newnsb/zX9oNK8tuI-Z"
        }
      ]
    },
    {
      "id": "cra",
      "url": "https://gawel.ch/regulatory-tracker/#reg-cra",
      "shortName": "CRA",
      "fullName": "Cyber Resilience Act",
      "citation": "Regulation (EU) 2024/2847",
      "jurisdiction": "EU",
      "domain": "cyber",
      "status": "phasing-in",
      "summary": "EU regulation on horizontal cybersecurity requirements for products with digital elements. Its notified-body rules (Art. 35–51 CRA) have applied since 11 June 2026 and its reporting obligations (Art. 14 CRA) since 11 September 2026; its main obligations apply from 11 December 2027.",
      "pairId": "product-cyber",
      "officialText": {
        "name": "Cyber Resilience Act",
        "url": "https://eur-lex.europa.eu/eli/reg/2024/2847/oj"
      },
      "relatedAnalysis": [
        {
          "title": "Cybersecurity for SaMD: Meeting MDR and Beyond",
          "url": "https://gawel.ch/insights/18-samd-cybersecurity/"
        }
      ],
      "milestones": [
        {
          "date": "2024-10-23",
          "label": "Signed by Parliament and Council",
          "kind": "enacted",
          "source": "https://eur-lex.europa.eu/eli/reg/2024/2847/oj"
        },
        {
          "date": "2024-12-10",
          "label": "Entry into force",
          "kind": "applied",
          "source": "https://eur-lex.europa.eu/eli/reg/2024/2847/oj"
        },
        {
          "date": "2026-06-11",
          "label": "Notified-body framework applies (Art. 35–51 CRA)",
          "kind": "applied",
          "source": "https://eur-lex.europa.eu/eli/reg/2024/2847/oj"
        },
        {
          "date": "2026-09-11",
          "label": "Reporting obligations (Art. 14 CRA) apply",
          "kind": "deadline",
          "source": "https://eur-lex.europa.eu/eli/reg/2024/2847/oj"
        },
        {
          "date": "2027-12-11",
          "label": "Main obligations apply",
          "kind": "deadline",
          "source": "https://eur-lex.europa.eu/eli/reg/2024/2847/oj"
        }
      ]
    },
    {
      "id": "ai-act",
      "url": "https://gawel.ch/regulatory-tracker/#reg-ai-act",
      "shortName": "AI Act",
      "fullName": "Artificial Intelligence Act",
      "citation": "Regulation (EU) 2024/1689",
      "jurisdiction": "EU",
      "domain": "ai",
      "status": "phasing-in",
      "summary": "EU horizontal regulation on artificial intelligence, applying risk-tiered obligations. The Digital Omnibus on AI (Regulation (EU) 2026/1744, in force since 27 July 2026) defers the high-risk obligations for standalone systems under Annex III AI Act to 2 December 2027 and for product-embedded systems under Annex I AI Act to 2 August 2028. Transparency obligations (Art. 50 AI Act) applied on schedule on 2 August 2026; generative systems already on the market before that date have until 2 December 2026 to meet the machine-readable marking requirement. The amending act also adds two prohibitions, of AI systems that generate non-consensual intimate imagery of an identifiable person or child sexual abuse material (Art. 5(1)(ba) and (bb) AI Act), which apply from 2 December 2026.",
      "pairId": "ai",
      "officialText": {
        "name": "Artificial Intelligence Act",
        "url": "https://eur-lex.europa.eu/eli/reg/2024/1689/2026-07-27"
      },
      "relatedAnalysis": [
        {
          "title": "AI-Enabled Medical Devices: The Regulatory Convergence Problem",
          "url": "https://gawel.ch/insights/14-ai-medical-devices/"
        },
        {
          "title": "EU AI Act and German Pharma R&D: The 2026–2027 Compliance Cliffs",
          "url": "https://gawel.ch/insights/24-eu-ai-act-german-pharma-rnd/"
        }
      ],
      "milestones": [
        {
          "date": "2024-06-13",
          "label": "Signed by Parliament and Council",
          "kind": "enacted",
          "source": "https://eur-lex.europa.eu/eli/reg/2024/1689/oj"
        },
        {
          "date": "2024-08-01",
          "label": "Entry into force",
          "kind": "applied",
          "source": "https://eur-lex.europa.eu/eli/reg/2024/1689/oj"
        },
        {
          "date": "2025-02-02",
          "label": "Prohibitions (Art. 5 AI Act) and AI-literacy duty (Art. 4 AI Act) apply",
          "kind": "applied",
          "source": "https://eur-lex.europa.eu/eli/reg/2024/1689/oj"
        },
        {
          "date": "2025-08-02",
          "label": "General-purpose AI (GPAI) model obligations, governance and penalties apply",
          "kind": "applied",
          "source": "https://eur-lex.europa.eu/eli/reg/2024/1689/oj"
        },
        {
          "date": "2026-08-02",
          "label": "Transparency obligations apply (Art. 50 AI Act; not deferred)",
          "kind": "applied",
          "source": "https://eur-lex.europa.eu/eli/reg/2024/1689/oj"
        },
        {
          "date": "2026-12-02",
          "label": "Marking grace period ends for pre-August-2026 generative systems (Art. 50(2) AI Act)",
          "kind": "deadline",
          "source": "https://eur-lex.europa.eu/eli/reg/2026/1744/oj"
        },
        {
          "date": "2026-12-02",
          "label": "Prohibitions of AI systems that generate non-consensual intimate imagery or child sexual abuse material apply (Art. 5(1)(ba) and (bb) AI Act, inserted by Reg (EU) 2026/1744)",
          "kind": "deadline",
          "source": "https://eur-lex.europa.eu/eli/reg/2026/1744/oj"
        },
        {
          "date": "2027-08-02",
          "label": "Legacy GPAI models must comply (Art. 111(3) AI Act)",
          "kind": "deadline",
          "source": "https://eur-lex.europa.eu/eli/reg/2024/1689/oj"
        },
        {
          "date": "2027-12-02",
          "label": "High-risk obligations for Annex III AI Act systems apply (deferred by Reg (EU) 2026/1744)",
          "kind": "deadline",
          "source": "https://eur-lex.europa.eu/eli/reg/2026/1744/oj"
        },
        {
          "date": "2028-08-02",
          "label": "High-risk obligations for Annex I AI Act product-embedded systems apply (deferred by Reg (EU) 2026/1744)",
          "kind": "deadline",
          "source": "https://eur-lex.europa.eu/eli/reg/2026/1744/oj"
        }
      ]
    },
    {
      "id": "ctr",
      "url": "https://gawel.ch/regulatory-tracker/#reg-ctr",
      "shortName": "CTR",
      "fullName": "Clinical Trials Regulation",
      "citation": "Regulation (EU) No 536/2014",
      "jurisdiction": "EU",
      "domain": "clinical",
      "status": "in-force",
      "summary": "EU regulation harmonizing clinical trial authorization and supervision through the Clinical Trials Information System (CTIS). The EU Pharma Package, once adopted, would amend it.",
      "pairId": "clinical-trials",
      "officialText": {
        "name": "Clinical Trials Regulation",
        "url": "https://eur-lex.europa.eu/eli/reg/2014/536/oj"
      },
      "relatedAnalysis": [
        {
          "title": "Cross-Border Clinical Trial Agreements: Swiss-EU Coordination Post-Brexit",
          "url": "https://gawel.ch/insights/20-cross-border-clinical-trial-agreements/"
        },
        {
          "title": "Austria's Accelerated Clinical Trial Pathway: What the 35-Day Timeline Does Not Tell US Biotech",
          "url": "https://gawel.ch/insights/25-austria-clinical-trial-pathway/"
        },
        {
          "title": "Clinical Trials with Pregnant Participants Under the EU CTR: The Gap Between Permission and Practice",
          "url": "https://gawel.ch/insights/28-eu-clinical-trials-pregnant-participants/"
        },
        {
          "title": "Clinical Trials with Pregnant Participants in Switzerland, the EU and the US: One Evidence Gap",
          "url": "https://gawel.ch/insights/30-comparative-clinical-trials-pregnant-participants/"
        }
      ],
      "milestones": [
        {
          "date": "2014-04-16",
          "label": "Signed by Parliament and Council",
          "kind": "enacted",
          "source": "https://eur-lex.europa.eu/eli/reg/2014/536/oj"
        },
        {
          "date": "2022-01-31",
          "label": "Date of application",
          "kind": "applied",
          "source": "https://eur-lex.europa.eu/eli/dec/2021/1240/oj"
        },
        {
          "date": "2025-01-31",
          "label": "Transition complete: all ongoing trials under the CTR in the Clinical Trials Information System (CTIS)",
          "kind": "applied",
          "source": "https://eur-lex.europa.eu/eli/reg/2014/536/oj"
        }
      ]
    },
    {
      "id": "hfg",
      "url": "https://gawel.ch/regulatory-tracker/#reg-hfg",
      "shortName": "HFG",
      "fullName": "Humanforschungsgesetz",
      "citation": "SR 810.30",
      "jurisdiction": "CH",
      "domain": "clinical",
      "status": "in-force",
      "summary": "Swiss human research act governing research on human diseases and on the structure and function of the human body, conducted with persons, on deceased persons, on embryos and fetuses, or with biological material or health-related personal data.",
      "pairId": "clinical-trials",
      "officialText": {
        "name": "Humanforschungsgesetz",
        "url": "https://www.fedlex.admin.ch/eli/cc/2013/617/de"
      },
      "relatedAnalysis": [
        {
          "title": "Clinical Trials with Pregnant Participants in Switzerland: When Protection Becomes Exclusion",
          "url": "https://gawel.ch/insights/27-swiss-clinical-trials-pregnant-participants/"
        }
      ],
      "milestones": [
        {
          "date": "2011-09-30",
          "label": "Adopted by Parliament (final vote)",
          "kind": "enacted",
          "source": "https://www.fedlex.admin.ch/eli/oc/2013/617/de"
        },
        {
          "date": "2014-01-01",
          "label": "Entry into force",
          "kind": "applied",
          "source": "https://www.fedlex.admin.ch/eli/oc/2013/617/de"
        },
        {
          "date": "2024-11-01",
          "label": "Revised ordinances on clinical trials (KlinV) and on human research (HFV) in force; KlinV registration and publication rules (Art. 64–67 KlinV) from 1 March 2025",
          "kind": "applied",
          "source": "https://www.fedlex.admin.ch/eli/oc/2024/322/de"
        }
      ]
    },
    {
      "id": "eu-pharma-package",
      "url": "https://gawel.ch/regulatory-tracker/#reg-eu-pharma-package",
      "shortName": "EU Pharma Package",
      "fullName": "EU Pharmaceutical Package (Regulation and Directive)",
      "citation": "Council first-reading positions ST-7105/26 (Regulation) and ST-7106/26 (Directive)",
      "jurisdiction": "EU",
      "domain": "pharma",
      "status": "upcoming",
      "summary": "Overhaul of EU pharmaceutical law that would replace Directive 2001/83/EC and Regulation (EC) No 726/2004, repeal the Orphan and Pediatric Regulations and absorb their rules, and amend (not replace) the ATMP Regulation and the CTR. Council and Parliament reached a provisional agreement in December 2025; in March 2026 Coreper endorsed the compromise text and the Parliament's health committee (SANT) approved it. The Council adopted its position at first reading on 28 September 2026. The Parliament's second-reading vote in plenary (indicatively 23 November 2026) is pending; the acts would then be published in the Official Journal and enter into force on the twentieth day after publication, and their main provisions would apply 24 months after entry into force, around 2028 to 2029. No Official Journal act has been published yet.",
      "pairId": "medicinal-products",
      "officialText": {
        "name": "Council position (Regulation)",
        "url": "https://data.consilium.europa.eu/doc/document/ST-7105-2026-INIT/en/pdf"
      },
      "officialTextAlso": {
        "name": "Council position (Directive)",
        "url": "https://data.consilium.europa.eu/doc/document/ST-7106-2026-INIT/en/pdf"
      },
      "relatedAnalysis": [
        {
          "title": "The 90-Day Rule: How the EU Pharma Package Rewrites Global Filing Strategy for US Sponsors",
          "url": "https://gawel.ch/insights/31-eu-pharma-package-global-filing-90-day-rule/"
        },
        {
          "title": "The New Orphan Math: Product-Based Exclusivity and What It Does to US Rare-Disease Biotech",
          "url": "https://gawel.ch/insights/32-eu-pharma-package-orphan-product-based-exclusivity/"
        },
        {
          "title": "Article 56a of the EU Pharma Package Directive: Access Conditionality and the New Cost of Selective EU Launch",
          "url": "https://gawel.ch/insights/33-eu-pharma-package-access-conditionality-article-56a/"
        },
        {
          "title": "Bolar at the Border: Expanded Carve-Outs and Earlier Generic and Biosimilar Entry into the EU",
          "url": "https://gawel.ch/insights/34-eu-pharma-package-bolar-expansion-tender-entry/"
        },
        {
          "title": "Transferable Exclusivity Vouchers: Will the EU's Antimicrobial Pull Incentive Actually Work for US AMR Developers?",
          "url": "https://gawel.ch/insights/35-eu-pharma-package-tev-antimicrobial-pull-incentive/"
        },
        {
          "title": "Environmental Risk Assessment Reaches Across the Pacific: Supply-Chain ERA Obligations for US Manufacturers Using Asian APIs",
          "url": "https://gawel.ch/insights/36-eu-pharma-package-era-supply-chain-non-eu-manufacturing/"
        },
        {
          "title": "Regulatory Sandboxes for Novel Therapies: A New EU Pathway for US Cell, Gene, and AI-Enabled Therapeutics",
          "url": "https://gawel.ch/insights/37-eu-pharma-package-regulatory-sandbox-novel-therapies/"
        }
      ],
      "milestones": [
        {
          "date": "2023-04-26",
          "label": "Commission proposals (COM(2023) 192 Directive and COM(2023) 193 Regulation)",
          "kind": "proposed",
          "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52023PC0192"
        },
        {
          "date": "2025-12-11",
          "label": "Provisional agreement between Council and Parliament",
          "kind": "procedural",
          "source": "https://www.consilium.europa.eu/en/press/press-releases/2025/12/11/pharma-package-council-and-parliament-reach-a-deal-on-new-rules-for-a-fairer-and-more-competitive-eu-pharmaceutical-sector/"
        },
        {
          "date": "2026-03-06",
          "label": "Committee of Permanent Representatives (Coreper) confirmed agreement on the final compromise text",
          "kind": "procedural",
          "source": "https://data.consilium.europa.eu/doc/document/ST-7104-2026-INIT/en/pdf"
        },
        {
          "date": "2026-03-18",
          "label": "Parliament's health committee (SANT) approved the agreed text",
          "kind": "procedural",
          "source": "https://oeil.europarl.europa.eu/oeil/en/procedure-file?reference=2023/0131(COD)"
        },
        {
          "date": "2026-09-28",
          "label": "Council adopted its position at first reading; Parliament's second-reading vote and publication remain pending",
          "kind": "procedural",
          "source": "https://data.consilium.europa.eu/doc/document/ST-7105-2026-REV-2-ADD-1/en/pdf"
        },
        {
          "date": "2026-11-23",
          "label": "Parliament plenary vote on the agreed text (indicative)",
          "kind": "procedural",
          "source": "https://oeil.europarl.europa.eu/oeil/en/procedure-file?reference=2023/0131(COD)"
        }
      ]
    },
    {
      "id": "dir-2001-83",
      "url": "https://gawel.ch/regulatory-tracker/#reg-dir-2001-83",
      "shortName": "Dir 2001/83/EC",
      "fullName": "Medicinal Products Code (current)",
      "citation": "Directive 2001/83/EC",
      "jurisdiction": "EU",
      "domain": "pharma",
      "status": "in-force",
      "summary": "Current EU code on medicinal products for human use. The EU Pharma Package, once adopted and applicable, would replace it.",
      "pairId": "medicinal-products",
      "officialText": {
        "name": "Medicinal Products Code (current)",
        "url": "https://eur-lex.europa.eu/eli/dir/2001/83/oj"
      },
      "relatedAnalysis": [
        {
          "title": "Pharma R&D Partnerships: Contractual Risk Allocation",
          "url": "https://gawel.ch/insights/01-pharma-rnd-partnerships/"
        },
        {
          "title": "ATMP GMP Manufacturing: Regulatory Gray Zones Between the EU and Switzerland",
          "url": "https://gawel.ch/insights/02-biotech-clinical-manufacturing/"
        },
        {
          "title": "AI in Drug Discovery: Intellectual Property and Data Ownership Challenges",
          "url": "https://gawel.ch/insights/16-ai-drug-discovery-ip/"
        }
      ],
      "milestones": [
        {
          "date": "2001-11-06",
          "label": "Signed by Parliament and Council",
          "kind": "enacted",
          "source": "https://eur-lex.europa.eu/eli/dir/2001/83/oj"
        }
      ]
    },
    {
      "id": "reg-726-2004",
      "url": "https://gawel.ch/regulatory-tracker/#reg-reg-726-2004",
      "shortName": "Reg 726/2004",
      "fullName": "Centralized Procedure Regulation (current)",
      "citation": "Regulation (EC) No 726/2004",
      "jurisdiction": "EU",
      "domain": "pharma",
      "status": "in-force",
      "summary": "Current EU centralized authorization procedure and EMA framework. The EU Pharma Package, once adopted and applicable, would replace it.",
      "pairId": "medicinal-products",
      "officialText": {
        "name": "Centralized Procedure Regulation (current)",
        "url": "https://eur-lex.europa.eu/eli/reg/2004/726/oj"
      },
      "relatedAnalysis": [
        {
          "title": "ATMP Hospital Exemption: Where Cell and Gene Therapy Licensing Ends",
          "url": "https://gawel.ch/insights/06-atmp-licensing-hospital-exemption/"
        }
      ],
      "milestones": [
        {
          "date": "2004-03-31",
          "label": "Signed by Parliament and Council",
          "kind": "enacted",
          "source": "https://eur-lex.europa.eu/eli/reg/2004/726/oj"
        }
      ]
    },
    {
      "id": "hmg",
      "url": "https://gawel.ch/regulatory-tracker/#reg-hmg",
      "shortName": "HMG",
      "fullName": "Heilmittelgesetz",
      "citation": "SR 812.21",
      "jurisdiction": "CH",
      "domain": "pharma",
      "status": "in-force",
      "summary": "Swiss federal therapeutic products act governing medicinal products and medical devices. A third revision is under way in two stages: 3a (digitalization, pediatric medication safety) is in Parliament; 3b (supply security) is in consultation.",
      "pairId": "medicinal-products",
      "officialText": {
        "name": "Heilmittelgesetz",
        "url": "https://www.fedlex.admin.ch/eli/cc/2001/422/de"
      },
      "relatedAnalysis": [
        {
          "title": "Swiss Pharma Pricing Under Pressure: What the Three-Year Review Means for R&D Investment",
          "url": "https://gawel.ch/insights/23-swiss-pharma-pricing-rnd/"
        },
        {
          "title": "ATMP Hospital Exemption: Where Cell and Gene Therapy Licensing Ends",
          "url": "https://gawel.ch/insights/06-atmp-licensing-hospital-exemption/"
        },
        {
          "title": "Swiss MedTech Export Without the MRA: What Third-Country Status Requires",
          "url": "https://gawel.ch/insights/21-swiss-medtech-export/"
        }
      ],
      "milestones": [
        {
          "date": "2000-12-15",
          "label": "Adopted by Parliament (final vote)",
          "kind": "enacted",
          "source": "https://www.fedlex.admin.ch/eli/cc/2001/422/de"
        },
        {
          "date": "2025-09-03",
          "label": "Federal Council dispatch on revision 3a adopted",
          "kind": "proposed",
          "source": "https://www.fedlex.admin.ch/eli/fga/2025/3017/de"
        },
        {
          "date": "2026-10-16",
          "label": "Revision 3b consultation closes",
          "kind": "deadline",
          "source": "https://fedlex.data.admin.ch/eli/dl/proj/2026/21/cons_1"
        }
      ]
    },
    {
      "id": "cma",
      "url": "https://gawel.ch/regulatory-tracker/#reg-cma",
      "shortName": "CMA",
      "fullName": "Critical Medicines Act",
      "citation": "COM(2025) 102 (Commission proposal); final compromise text ST-11059/26",
      "jurisdiction": "EU",
      "domain": "pharma",
      "status": "upcoming",
      "summary": "EU regulation to secure the supply of critical medicines, agreed but not yet adopted: procurement resilience criteria, contingency stocks and collaborative procurement. Parliament and Council reached a provisional agreement in May 2026, Coreper endorsed the final compromise text on 30 June 2026, and the Parliament's health committee (SANT) approved it on 14 July 2026; the Parliament plenary vote (indicatively 23 November 2026), adoption by the Council and Official Journal publication remain pending.",
      "pairId": "critical-medicines",
      "milestones": [
        {
          "date": "2025-03-11",
          "label": "Commission proposal",
          "kind": "proposed",
          "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52025PC0102"
        },
        {
          "date": "2026-05-12",
          "label": "Provisional agreement between Council and Parliament",
          "kind": "procedural",
          "source": "https://www.europarl.europa.eu/news/en/press-room/20260511IPR43110/deal-on-tackling-eu-shortages-of-essential-medicines"
        },
        {
          "date": "2026-06-30",
          "label": "Coreper endorsed the final compromise text",
          "kind": "procedural",
          "source": "https://data.consilium.europa.eu/doc/document/ST-11059-2026-INIT/en/pdf"
        },
        {
          "date": "2026-07-14",
          "label": "Parliament's health committee (SANT) approved the agreed text",
          "kind": "procedural",
          "source": "https://oeil.europarl.europa.eu/oeil/en/procedure-file?reference=2025/0102(COD)"
        },
        {
          "date": "2026-11-23",
          "label": "Parliament plenary vote on the agreed text (indicative)",
          "kind": "procedural",
          "source": "https://oeil.europarl.europa.eu/oeil/en/procedure-file?reference=2025/0102(COD)"
        }
      ]
    },
    {
      "id": "lvg",
      "url": "https://gawel.ch/regulatory-tracker/#reg-lvg",
      "shortName": "LVG",
      "fullName": "Landesversorgungsgesetz",
      "citation": "SR 531",
      "jurisdiction": "CH",
      "domain": "pharma",
      "status": "in-force",
      "summary": "Swiss economic supply-security act: mandatory stockpiles (Pflichtlager) for essential medicines and reporting of supply disruptions, the functional counterpart to the EU's critical-medicines initiative.",
      "pairId": "critical-medicines",
      "officialText": {
        "name": "Landesversorgungsgesetz",
        "url": "https://www.fedlex.admin.ch/eli/cc/2017/308/de"
      },
      "milestones": [
        {
          "date": "2016-06-17",
          "label": "Adopted by Parliament (final vote)",
          "kind": "enacted",
          "source": "https://www.fedlex.admin.ch/eli/cc/2017/308/de"
        },
        {
          "date": "2017-06-01",
          "label": "Totally revised LVG in force",
          "kind": "applied",
          "source": "https://www.fedlex.admin.ch/eli/cc/2017/308/de"
        },
        {
          "date": "2025-06-20",
          "label": "Amendment reorganizing the economic supply organization adopted by Parliament (final vote)",
          "kind": "enacted",
          "source": "https://www.fedlex.admin.ch/eli/oc/2025/618/de"
        },
        {
          "date": "2025-11-01",
          "label": "Amendment in force",
          "kind": "applied",
          "source": "https://www.fedlex.admin.ch/eli/oc/2025/618/de"
        }
      ]
    },
    {
      "id": "gmp-chapter-4",
      "url": "https://gawel.ch/regulatory-tracker/#reg-gmp-chapter-4",
      "shortName": "GMP Ch. 4",
      "fullName": "EU GMP Guide Chapter 4: Documentation",
      "citation": "EudraLex Volume 4, Chapter 4 (Documentation)",
      "jurisdiction": "EU",
      "domain": "gmp",
      "status": "proposed",
      "summary": "Revised GMP documentation chapter; risk-management and data-governance principles, draft under finalization.",
      "pairId": "gmp",
      "officialText": {
        "name": "EU GMP Guide Chapter 4: Documentation",
        "url": "https://health.ec.europa.eu/document/download/fa336a6e-753b-46fc-b53b-9178bacd8878_en?filename=mp_vol4_chap4_consultation_guideline_en.pdf"
      },
      "milestones": [
        {
          "date": "2025-07-07",
          "label": "Draft published for consultation",
          "kind": "proposed",
          "source": "https://health.ec.europa.eu/consultations/stakeholders-consultation-eudralex-volume-4-good-manufacturing-practice-guidelines-chapter-4-annex_en"
        },
        {
          "date": "2025-10-07",
          "label": "Consultation closed",
          "kind": "deadline",
          "source": "https://health.ec.europa.eu/consultations/stakeholders-consultation-eudralex-volume-4-good-manufacturing-practice-guidelines-chapter-4-annex_en"
        }
      ]
    },
    {
      "id": "gmp-annex-11",
      "url": "https://gawel.ch/regulatory-tracker/#reg-gmp-annex-11",
      "shortName": "GMP Annex 11",
      "fullName": "EU GMP Guide Annex 11: Computerised Systems",
      "citation": "EudraLex Volume 4, Annex 11 (Computerised Systems)",
      "jurisdiction": "EU",
      "domain": "gmp",
      "status": "proposed",
      "summary": "Major revision of the computerized-systems annex (expanded from 5 to 19 pages); draft under finalization.",
      "pairId": "gmp",
      "officialText": {
        "name": "EU GMP Guide Annex 11: Computerised Systems",
        "url": "https://health.ec.europa.eu/document/download/40231f18-e564-4043-94de-c031f813d38b_en?filename=mp_vol4_chap4_annex11_consultation_guideline_en.pdf"
      },
      "relatedAnalysis": [
        {
          "title": "EU AI Act and German Pharma R&D: The 2026–2027 Compliance Cliffs",
          "url": "https://gawel.ch/insights/24-eu-ai-act-german-pharma-rnd/"
        },
        {
          "title": "Nordic NIS2 Enforcement: Five Countries, Two Regimes, and Separate Supervisors for Pharma R&D",
          "url": "https://gawel.ch/insights/26-nordic-nis2-pharma-rnd/"
        }
      ],
      "milestones": [
        {
          "date": "2025-07-07",
          "label": "Draft published for consultation",
          "kind": "proposed",
          "source": "https://health.ec.europa.eu/consultations/stakeholders-consultation-eudralex-volume-4-good-manufacturing-practice-guidelines-chapter-4-annex_en"
        },
        {
          "date": "2025-10-07",
          "label": "Consultation closed",
          "kind": "deadline",
          "source": "https://health.ec.europa.eu/consultations/stakeholders-consultation-eudralex-volume-4-good-manufacturing-practice-guidelines-chapter-4-annex_en"
        }
      ]
    },
    {
      "id": "gmp-annex-22",
      "url": "https://gawel.ch/regulatory-tracker/#reg-gmp-annex-22",
      "shortName": "GMP Annex 22",
      "fullName": "EU GMP Guide Annex 22: Artificial Intelligence",
      "citation": "EudraLex Volume 4, Annex 22 (Artificial Intelligence)",
      "jurisdiction": "EU",
      "domain": "gmp",
      "status": "proposed",
      "summary": "First GMP annex on artificial intelligence and machine learning (AI/ML) in manufacturing: static, deterministic models for critical GMP applications. The draft excludes generative AI from critical use, an exclusion under review after the June 2026 EMA workshop.",
      "pairId": "gmp",
      "officialText": {
        "name": "EU GMP Guide Annex 22: Artificial Intelligence",
        "url": "https://health.ec.europa.eu/document/download/5f38a92d-bb8e-4264-8898-ea076e926db6_en?filename=mp_vol4_chap4_annex22_consultation_guideline_en.pdf"
      },
      "milestones": [
        {
          "date": "2025-07-07",
          "label": "Draft published for consultation",
          "kind": "proposed",
          "source": "https://health.ec.europa.eu/consultations/stakeholders-consultation-eudralex-volume-4-good-manufacturing-practice-guidelines-chapter-4-annex_en"
        },
        {
          "date": "2025-10-07",
          "label": "Consultation closed",
          "kind": "deadline",
          "source": "https://health.ec.europa.eu/consultations/stakeholders-consultation-eudralex-volume-4-good-manufacturing-practice-guidelines-chapter-4-annex_en"
        },
        {
          "date": "2026-06-30",
          "label": "European Medicines Agency (EMA) multistakeholder workshop on generative-AI scope",
          "kind": "procedural",
          "source": "https://www.ema.europa.eu/en/events/good-manufacturing-practice-multistakeholder-workshop-expert-contributions-artificial-intelligence-guidance-development-annex-22"
        }
      ]
    },
    {
      "id": "swiss-gmp",
      "url": "https://gawel.ch/regulatory-tracker/#reg-swiss-gmp",
      "shortName": "AMBV",
      "fullName": "Arzneimittel-Bewilligungsverordnung (Swiss GMP / PIC/S)",
      "citation": "AMBV (SR 812.212.1); PIC/S GMP Guide",
      "jurisdiction": "CH",
      "domain": "gmp",
      "status": "in-force",
      "summary": "Switzerland's GMP rules are listed in Annex 1 AMBV under the HMG; they include the EU GMP Guide (EudraLex Volume 4) and the GMP guidelines of the Pharmaceutical Inspection Co-operation Scheme (PIC/S).",
      "pairId": "gmp",
      "officialText": {
        "name": "Arzneimittel-Bewilligungsverordnung (Swiss GMP / PIC/S)",
        "url": "https://www.fedlex.admin.ch/eli/cc/2018/786/de"
      },
      "milestones": [
        {
          "date": "2018-11-14",
          "label": "Adopted by the Federal Council",
          "kind": "enacted",
          "source": "https://www.fedlex.admin.ch/eli/cc/2018/786/de"
        }
      ]
    },
    {
      "id": "pld",
      "url": "https://gawel.ch/regulatory-tracker/#reg-pld",
      "shortName": "PLD",
      "fullName": "Product Liability Directive (revised)",
      "citation": "Directive (EU) 2024/2853",
      "jurisdiction": "EU",
      "domain": "liability",
      "status": "upcoming",
      "summary": "Revised EU product-liability regime covering software, AI systems and digital products. It applies to products placed on the market or put into service after 9 December 2026 and replaces Directive 85/374/EEC, which continues to apply to products placed on the market or put into service before that date.",
      "pairId": "product-liability",
      "officialText": {
        "name": "Product Liability Directive (revised)",
        "url": "https://eur-lex.europa.eu/eli/dir/2024/2853/oj"
      },
      "relatedAnalysis": [
        {
          "title": "Pharma Supply Chain Liability: When Contracts Meet Reality",
          "url": "https://gawel.ch/insights/04-pharma-supply-chain-liability/"
        },
        {
          "title": "AI-Enabled Medical Devices: The Regulatory Convergence Problem",
          "url": "https://gawel.ch/insights/14-ai-medical-devices/"
        }
      ],
      "milestones": [
        {
          "date": "2024-10-23",
          "label": "Signed by Parliament and Council",
          "kind": "enacted",
          "source": "https://eur-lex.europa.eu/eli/dir/2024/2853/oj"
        },
        {
          "date": "2024-12-08",
          "label": "Entry into force",
          "kind": "applied",
          "source": "https://eur-lex.europa.eu/eli/dir/2024/2853/oj"
        },
        {
          "date": "2026-12-09",
          "label": "Member-State transposition deadline",
          "kind": "deadline",
          "source": "https://eur-lex.europa.eu/eli/dir/2024/2853/oj"
        }
      ]
    },
    {
      "id": "prhg",
      "url": "https://gawel.ch/regulatory-tracker/#reg-prhg",
      "shortName": "PrHG",
      "fullName": "Produktehaftpflichtgesetz",
      "citation": "SR 221.112.944",
      "jurisdiction": "CH",
      "domain": "liability",
      "status": "in-force",
      "summary": "Swiss product liability act. Unlike the revised EU PLD, it has not been extended to software and AI, and no revision is pending.",
      "pairId": "product-liability",
      "officialText": {
        "name": "Produktehaftpflichtgesetz",
        "url": "https://www.fedlex.admin.ch/eli/cc/1993/3122_3122_3122/de"
      },
      "relatedAnalysis": [
        {
          "title": "Pharma Supply Chain Liability: When Contracts Meet Reality",
          "url": "https://gawel.ch/insights/04-pharma-supply-chain-liability/"
        }
      ],
      "milestones": [
        {
          "date": "1993-06-18",
          "label": "Adopted by Parliament (final vote)",
          "kind": "enacted",
          "source": "https://www.fedlex.admin.ch/eli/cc/1993/3122_3122_3122/de"
        }
      ]
    },
    {
      "id": "spc-eu",
      "url": "https://gawel.ch/regulatory-tracker/#reg-spc-eu",
      "shortName": "SPC",
      "fullName": "Supplementary Protection Certificate",
      "citation": "Regulation (EC) No 469/2009",
      "jurisdiction": "EU",
      "domain": "pharma",
      "status": "in-force",
      "summary": "EU supplementary protection certificates extending patent-like protection for authorized medicinal products. The 2023 unitary-SPC and recast reform package remains pending in Council.",
      "pairId": "spc",
      "officialText": {
        "name": "Supplementary Protection Certificate",
        "url": "https://eur-lex.europa.eu/eli/reg/2009/469/oj"
      },
      "relatedAnalysis": [
        {
          "title": "Parallel Imports in Switzerland: Protection Under Pharma Distribution Agreements",
          "url": "https://gawel.ch/insights/08-pharma-distribution-parallel-imports/"
        },
        {
          "title": "Biotech Licensing: Hidden Contractual Pitfalls",
          "url": "https://gawel.ch/insights/13-biotech-licensing-pitfalls/"
        }
      ],
      "milestones": [
        {
          "date": "2009-05-06",
          "label": "Signed by Parliament and Council (codified version)",
          "kind": "enacted",
          "source": "https://eur-lex.europa.eu/eli/reg/2009/469/oj"
        }
      ]
    },
    {
      "id": "spc-ch",
      "url": "https://gawel.ch/regulatory-tracker/#reg-spc-ch",
      "shortName": "ESZ",
      "fullName": "Ergänzendes Schutzzertifikat (Swiss SPC)",
      "citation": "Art. 140a ff. PatG (SR 232.14)",
      "jurisdiction": "CH",
      "domain": "pharma",
      "status": "in-force",
      "summary": "Swiss supplementary protection certificate under the Patentgesetz, mirroring the EU SPC mechanism.",
      "pairId": "spc",
      "officialText": {
        "name": "Ergänzendes Schutzzertifikat (Swiss SPC)",
        "url": "https://www.fedlex.admin.ch/eli/cc/1955/871_893_899/de"
      },
      "relatedAnalysis": [
        {
          "title": "Biotech Licensing: Hidden Contractual Pitfalls",
          "url": "https://gawel.ch/insights/13-biotech-licensing-pitfalls/"
        }
      ],
      "milestones": [
        {
          "date": "1995-02-03",
          "label": "SPC provisions adopted by Parliament (PatG amendment, final vote)",
          "kind": "enacted",
          "source": "https://www.fedlex.admin.ch/eli/oc/1995/2879_2879_2879/de"
        }
      ]
    },
    {
      "id": "atmp",
      "url": "https://gawel.ch/regulatory-tracker/#reg-atmp",
      "shortName": "ATMP Reg",
      "fullName": "Advanced Therapy Medicinal Products Regulation",
      "citation": "Regulation (EC) No 1394/2007",
      "jurisdiction": "EU",
      "domain": "pharma",
      "status": "in-force",
      "summary": "EU framework for gene-therapy, somatic-cell-therapy and tissue-engineered products. The EU Pharma Package, once adopted, would amend it but not replace it.",
      "pairId": "atmp",
      "officialText": {
        "name": "Advanced Therapy Medicinal Products Regulation",
        "url": "https://eur-lex.europa.eu/eli/reg/2007/1394/oj"
      },
      "relatedAnalysis": [
        {
          "title": "ATMP GMP Manufacturing: Regulatory Gray Zones Between the EU and Switzerland",
          "url": "https://gawel.ch/insights/02-biotech-clinical-manufacturing/"
        },
        {
          "title": "ATMP Hospital Exemption: Where Cell and Gene Therapy Licensing Ends",
          "url": "https://gawel.ch/insights/06-atmp-licensing-hospital-exemption/"
        }
      ],
      "milestones": [
        {
          "date": "2007-11-13",
          "label": "Signed by Parliament and Council",
          "kind": "enacted",
          "source": "https://eur-lex.europa.eu/eli/reg/2007/1394/oj"
        }
      ]
    },
    {
      "id": "atmp-ch",
      "url": "https://gawel.ch/regulatory-tracker/#reg-atmp-ch",
      "shortName": "TxG/HMG (ATMP)",
      "fullName": "Transplantationsgesetz and Heilmittelgesetz (ATMP rules)",
      "citation": "SR 810.21; SR 812.21",
      "jurisdiction": "CH",
      "domain": "pharma",
      "status": "in-force",
      "summary": "Switzerland regulates ATMPs functionally rather than in one act: cell- and tissue-based products as transplant products (Transplantatprodukte) under the TxG in conjunction with the HMG, gene-therapy products under the HMG; Swissmedic authorizes both.",
      "pairId": "atmp",
      "officialText": {
        "name": "TxG",
        "url": "https://www.fedlex.admin.ch/eli/cc/2007/279/de"
      },
      "officialTextAlso": {
        "name": "HMG",
        "url": "https://www.fedlex.admin.ch/eli/cc/2001/422/de"
      },
      "relatedAnalysis": [
        {
          "title": "ATMP Hospital Exemption: Where Cell and Gene Therapy Licensing Ends",
          "url": "https://gawel.ch/insights/06-atmp-licensing-hospital-exemption/"
        }
      ],
      "milestones": [
        {
          "date": "2004-10-08",
          "label": "TxG adopted by Parliament (final vote)",
          "kind": "enacted",
          "source": "https://www.fedlex.admin.ch/eli/cc/2007/279/de"
        },
        {
          "date": "2007-07-01",
          "label": "TxG entry into force",
          "kind": "applied",
          "source": "https://www.fedlex.admin.ch/eli/cc/2007/279/de"
        },
        {
          "date": "2023-09-29",
          "label": "TxG revision adopted by Parliament",
          "kind": "enacted",
          "source": "https://www.fedlex.admin.ch/eli/fga/2023/2294/de"
        }
      ]
    },
    {
      "id": "soho",
      "url": "https://gawel.ch/regulatory-tracker/#reg-soho",
      "shortName": "SoHO Reg",
      "fullName": "Substances of Human Origin Regulation",
      "citation": "Regulation (EU) 2024/1938",
      "jurisdiction": "EU",
      "domain": "pharma",
      "status": "upcoming",
      "summary": "EU framework on the quality and safety of substances of human origin (blood, tissues, cells) used in humans or to manufacture products, replacing the Blood Directive and the Tissues and Cells Directive.",
      "pairId": "soho",
      "officialText": {
        "name": "Substances of Human Origin Regulation",
        "url": "https://eur-lex.europa.eu/eli/reg/2024/1938/oj"
      },
      "milestones": [
        {
          "date": "2024-06-13",
          "label": "Signed by Parliament and Council",
          "kind": "enacted",
          "source": "https://eur-lex.europa.eu/eli/reg/2024/1938/oj"
        },
        {
          "date": "2024-08-06",
          "label": "Entry into force",
          "kind": "applied",
          "source": "https://eur-lex.europa.eu/eli/reg/2024/1938/oj"
        },
        {
          "date": "2027-08-07",
          "label": "Main obligations apply",
          "kind": "deadline",
          "source": "https://eur-lex.europa.eu/eli/reg/2024/1938/oj"
        },
        {
          "date": "2028-08-07",
          "label": "Penalties apply; legacy blood and tissue establishments and their preparations are verified and recorded on the EU SoHO Platform",
          "kind": "deadline",
          "source": "https://eur-lex.europa.eu/eli/reg/2024/1938/oj"
        }
      ]
    },
    {
      "id": "soho-ch",
      "url": "https://gawel.ch/regulatory-tracker/#reg-soho-ch",
      "shortName": "HMG/TxG (SoHO)",
      "fullName": "Heilmittelgesetz and Transplantationsgesetz (SoHO coverage)",
      "citation": "SR 812.21; SR 810.21",
      "jurisdiction": "CH",
      "domain": "pharma",
      "status": "in-force",
      "summary": "Swiss coverage of substances of human origin is split: labile blood and blood products under the HMG, tissues and cells for transplantation under the TxG; no single SoHO-equivalent act exists.",
      "pairId": "soho",
      "officialText": {
        "name": "TxG",
        "url": "https://www.fedlex.admin.ch/eli/cc/2007/279/de"
      },
      "officialTextAlso": {
        "name": "HMG",
        "url": "https://www.fedlex.admin.ch/eli/cc/2001/422/de"
      },
      "milestones": [
        {
          "date": "2004-10-08",
          "label": "TxG adopted by Parliament (final vote)",
          "kind": "enacted",
          "source": "https://www.fedlex.admin.ch/eli/cc/2007/279/de"
        }
      ]
    },
    {
      "id": "hta",
      "url": "https://gawel.ch/regulatory-tracker/#reg-hta",
      "shortName": "HTA Reg",
      "fullName": "Health Technology Assessment Regulation",
      "citation": "Regulation (EU) 2021/2282",
      "jurisdiction": "EU",
      "domain": "pharma",
      "status": "phasing-in",
      "summary": "EU joint clinical assessment of health technologies, applying first to oncology medicines and ATMPs; high-risk medical devices and class D in vitro diagnostics are assessed once the Commission selects them by implementing act.",
      "pairId": "hta",
      "officialText": {
        "name": "Health Technology Assessment Regulation",
        "url": "https://eur-lex.europa.eu/eli/reg/2021/2282/oj"
      },
      "milestones": [
        {
          "date": "2021-12-15",
          "label": "Signed by Parliament and Council",
          "kind": "enacted",
          "source": "https://eur-lex.europa.eu/eli/reg/2021/2282/oj"
        },
        {
          "date": "2025-01-12",
          "label": "Application begins (oncology / ATMPs first)",
          "kind": "applied",
          "source": "https://eur-lex.europa.eu/eli/reg/2021/2282/oj"
        },
        {
          "date": "2028-01-13",
          "label": "Joint clinical assessment extends to orphan medicinal products",
          "kind": "deadline",
          "source": "https://eur-lex.europa.eu/eli/reg/2021/2282/oj"
        },
        {
          "date": "2030-01-13",
          "label": "Joint clinical assessment extends to all other medicinal products in its scope (Art. 7(2)(c) HTA Regulation)",
          "kind": "deadline",
          "source": "https://eur-lex.europa.eu/eli/reg/2021/2282/oj"
        }
      ]
    },
    {
      "id": "orphan",
      "url": "https://gawel.ch/regulatory-tracker/#reg-orphan",
      "shortName": "Orphan Reg",
      "fullName": "Orphan Medicinal Products Regulation",
      "citation": "Regulation (EC) No 141/2000",
      "jurisdiction": "EU",
      "domain": "pharma",
      "status": "in-force",
      "summary": "EU incentives and market exclusivity for orphan medicinal products. The EU Pharma Package, once adopted and applicable, would repeal it and absorb its rules.",
      "pairId": "orphan",
      "officialText": {
        "name": "Orphan Medicinal Products Regulation",
        "url": "https://eur-lex.europa.eu/eli/reg/2000/141/oj"
      },
      "relatedAnalysis": [
        {
          "title": "The New Orphan Math: Product-Based Exclusivity and What It Does to US Rare-Disease Biotech",
          "url": "https://gawel.ch/insights/32-eu-pharma-package-orphan-product-based-exclusivity/"
        }
      ],
      "milestones": [
        {
          "date": "1999-12-16",
          "label": "Signed by Parliament and Council",
          "kind": "enacted",
          "source": "https://eur-lex.europa.eu/eli/reg/2000/141/oj"
        }
      ]
    },
    {
      "id": "orphan-ch",
      "url": "https://gawel.ch/regulatory-tracker/#reg-orphan-ch",
      "shortName": "HMG (Orphan)",
      "fullName": "Heilmittelgesetz orphan-drug regime",
      "citation": "Art. 4 Abs. 1 Bst. adecies, Art. 14 Abs. 1 Bst. f, Art. 11b Abs. 4 HMG (SR 812.21)",
      "jurisdiction": "CH",
      "domain": "pharma",
      "status": "in-force",
      "summary": "Swiss orphan regime since 2019: orphan status granted by Swissmedic, simplified authorization, and 15 years of Unterlagenschutz (data exclusivity) under Art. 11b Abs. 4 HMG, unlike the EU's 10-year market exclusivity.",
      "pairId": "orphan",
      "officialText": {
        "name": "Heilmittelgesetz orphan-drug regime",
        "url": "https://www.fedlex.admin.ch/eli/cc/2001/422/de"
      },
      "milestones": [
        {
          "date": "2016-03-18",
          "label": "Orphan-drug provisions adopted by Parliament (HMG amendment, final vote)",
          "kind": "enacted",
          "source": "https://www.fedlex.admin.ch/eli/oc/2017/280/de"
        },
        {
          "date": "2019-01-01",
          "label": "Revised HMG orphan provisions in force",
          "kind": "applied",
          "source": "https://www.fedlex.admin.ch/eli/oc/2018/587/de"
        }
      ]
    },
    {
      "id": "paediatric",
      "url": "https://gawel.ch/regulatory-tracker/#reg-paediatric",
      "shortName": "Pediatric Reg",
      "fullName": "Pediatric Medicines Regulation",
      "citation": "Regulation (EC) No 1901/2006",
      "jurisdiction": "EU",
      "domain": "pharma",
      "status": "in-force",
      "summary": "EU framework on medicines for pediatric use. The EU Pharma Package, once adopted and applicable, would repeal it and absorb its rules.",
      "pairId": "paediatric",
      "officialText": {
        "name": "Pediatric Medicines Regulation",
        "url": "https://eur-lex.europa.eu/eli/reg/2006/1901/oj"
      },
      "milestones": [
        {
          "date": "2006-12-12",
          "label": "Signed by Parliament and Council",
          "kind": "enacted",
          "source": "https://eur-lex.europa.eu/eli/reg/2006/1901/oj"
        }
      ]
    },
    {
      "id": "paediatric-ch",
      "url": "https://gawel.ch/regulatory-tracker/#reg-paediatric-ch",
      "shortName": "HMG/PatG",
      "fullName": "Heilmittelgesetz and Patentgesetz pediatric provisions",
      "citation": "Art. 54a ff. HMG; Art. 140n and 140t PatG",
      "jurisdiction": "CH",
      "domain": "pharma",
      "status": "in-force",
      "summary": "Swiss pediatric regime since 2019: pediatric investigation plan duty under Art. 54a ff. HMG, a six-month pediatric extension of the ESZ under Art. 140n PatG, and a standalone pediatric certificate under Art. 140t PatG.",
      "pairId": "paediatric",
      "officialText": {
        "name": "HMG",
        "url": "https://www.fedlex.admin.ch/eli/cc/2001/422/de"
      },
      "officialTextAlso": {
        "name": "PatG",
        "url": "https://www.fedlex.admin.ch/eli/cc/1955/871_893_899/de"
      },
      "milestones": [
        {
          "date": "2016-03-18",
          "label": "Pediatric provisions adopted by Parliament (HMG and PatG amendment, final vote)",
          "kind": "enacted",
          "source": "https://www.fedlex.admin.ch/eli/oc/2017/280/de"
        },
        {
          "date": "2019-01-01",
          "label": "Pediatric provisions of the revised HMG and PatG in force",
          "kind": "applied",
          "source": "https://www.fedlex.admin.ch/eli/oc/2018/587/de"
        }
      ]
    },
    {
      "id": "patg-ch",
      "url": "https://gawel.ch/regulatory-tracker/#reg-patg-ch",
      "shortName": "PatG",
      "fullName": "Patentgesetz (Patent Act)",
      "citation": "SR 232.14; amendment of 15 March 2024 (AS 2026 232)",
      "jurisdiction": "CH",
      "domain": "pharma",
      "status": "in-force",
      "summary": "Swiss patent act. From 1 January 2027 a revised patent-grant procedure applies: the IGE, the Swiss patent office, arranges for a report on the state of the art to be prepared and published (Art. 57a PatG) and, at the request of the applicant or a third party, also examines novelty and inventive step (Art. 58b PatG).",
      "pairId": "patent-grant",
      "officialText": {
        "name": "Patentgesetz (Patent Act)",
        "url": "https://www.fedlex.admin.ch/eli/cc/1955/871_893_899/de"
      },
      "milestones": [
        {
          "date": "1954-06-25",
          "label": "Adopted by Parliament (final vote)",
          "kind": "enacted",
          "source": "https://www.fedlex.admin.ch/eli/cc/1955/871_893_899/de"
        },
        {
          "date": "2024-03-15",
          "label": "Patent-procedure revision passed in the final vote",
          "kind": "enacted",
          "source": "https://www.fedlex.admin.ch/eli/oc/2026/232/de"
        },
        {
          "date": "2027-01-01",
          "label": "Revised patent-grant procedure in force",
          "kind": "applied",
          "source": "https://www.fedlex.admin.ch/eli/oc/2026/232/de"
        }
      ]
    },
    {
      "id": "kg",
      "url": "https://gawel.ch/regulatory-tracker/#reg-kg",
      "shortName": "KG",
      "fullName": "Kartellgesetz",
      "citation": "SR 251",
      "jurisdiction": "CH",
      "domain": "competition",
      "status": "in-force",
      "summary": "Swiss cartel act. The 2025 partial revision replaces the qualified-dominance test in merger control with the SIEC test (significant impediment to effective competition). The referendum period ended on 17 April 2026 with no referendum announced, and the Federal Council has not yet published the date of entry into force, which it sets. A second bill, reforming the competition authorities, went to Parliament with the Federal Council's dispatch of 20 May 2026.",
      "pairId": "competition",
      "officialText": {
        "name": "Kartellgesetz",
        "url": "https://www.fedlex.admin.ch/eli/cc/1996/546_546_546/de"
      },
      "relatedAnalysis": [
        {
          "title": "Swiss Merger Control Adopts the SIEC Test: The Revised Kartellgesetz and US MedTech and Pharma Deals",
          "url": "https://gawel.ch/insights/62-swiss-kartellgesetz-siec-weko-merger-control/"
        }
      ],
      "milestones": [
        {
          "date": "1995-10-06",
          "label": "Adopted by Parliament (final vote)",
          "kind": "enacted",
          "source": "https://www.fedlex.admin.ch/eli/cc/1996/546_546_546/de"
        },
        {
          "date": "2025-12-19",
          "label": "Merger-control revision (SIEC test: significant impediment to effective competition) passed in the final vote",
          "kind": "enacted",
          "source": "https://www.fedlex.admin.ch/eli/fga/2026/18/de"
        },
        {
          "date": "2026-04-17",
          "label": "Referendum deadline for the merger-control revision",
          "kind": "deadline",
          "source": "https://www.fedlex.admin.ch/eli/fga/2026/18/de"
        },
        {
          "date": "2026-05-20",
          "label": "Federal Council dispatch on the competition-authorities reform, a second KG bill",
          "kind": "proposed",
          "source": "https://www.fedlex.admin.ch/eli/fga/2026/1594/de"
        },
        {
          "date": "2026-09-17",
          "label": "Implementing-ordinance consultation closed",
          "kind": "deadline",
          "source": "https://fedlex.data.admin.ch/eli/dl/proj/2026/12/cons_1"
        }
      ]
    }
  ]
}