Regulatory tracker

EU and Swiss regulatory dates for life sciences and technology

Last reviewed

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Regulatory timeline

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Timeline and status key

Milestones before the review date are collapsed under Earlier milestones; later milestones are grouped by period. Each entry links to its summary below, which gives the official sources.

  • Adopted: signed by Parliament and Council (EU), or passed by Parliament or adopted by the Federal Council (CH)
  • Applies: in force or applicable
  • Deadline: a transition or compliance date
  • Proposed: a proposal, a draft or a Federal Council dispatch (Botschaft)
  • Procedural step: a treaty signature, a provisional agreement, a committee or plenary vote, a workshop

Each instrument summary carries a status. In force: the instrument applies, though transitional periods may still run. Phasing in: the instrument is in force, with further obligations or national transposition still to take effect. Upcoming: the instrument is adopted, agreed or signed but does not apply yet. Proposed: the instrument is a draft or proposal still under consultation or negotiation.

Earlier milestones104 milestones
  1. CH PatG Adopted by Parliament (final vote)
  2. CH PrHG Adopted by Parliament (final vote)
  3. CH ESZ SPC provisions adopted by Parliament (PatG amendment, final vote)
  4. CH KG Adopted by Parliament (final vote)
  5. EU Orphan Reg Signed by Parliament and Council
  6. CH HMG Adopted by Parliament (final vote)
  7. EU Dir 2001/83/EC Signed by Parliament and Council
  8. EU Reg 726/2004 Signed by Parliament and Council
  9. CH TxG/HMG (ATMP) TxG adopted by Parliament (final vote)
  10. CH HMG/TxG (SoHO) TxG adopted by Parliament (final vote)
  11. EU Pediatric Reg Signed by Parliament and Council
  12. CH TxG/HMG (ATMP) TxG entry into force
  13. EU ATMP Reg Signed by Parliament and Council
  14. EU SPC Signed by Parliament and Council (codified version)
  15. CH HFG Adopted by Parliament (final vote)
  16. CH HFG Entry into force
  17. EU CTR Signed by Parliament and Council
  18. CH EPDG Adopted by Parliament (final vote)
  19. CH HMG (Orphan) Orphan-drug provisions adopted by Parliament (HMG amendment, final vote)
  20. CH HMG/PatG Pediatric provisions adopted by Parliament (HMG and PatG amendment, final vote)
  21. EU GDPR Signed by Parliament and Council
  22. CH LVG Adopted by Parliament (final vote)
  23. EU MDR Signed by Parliament and Council
  24. EU IVDR Signed by Parliament and Council
  25. CH EPDG Entry into force
  26. CH LVG Totally revised LVG in force
  27. EU GDPR Date of application
  28. CH AMBV Adopted by the Federal Council
  29. CH HMG (Orphan) Revised HMG orphan provisions in force
  30. CH HMG/PatG Pediatric provisions of the revised HMG and PatG in force
  31. CH MepV Adopted by the Federal Council
  32. CH DSG Adopted by Parliament (final vote)
  33. CH ISG Adopted by Parliament (final vote)
  34. EU MDR Date of application
  35. CH MepV Entry into force (revised)
  36. EU HTA Reg Signed by Parliament and Council
  37. EU CTR Date of application
  38. CH IvDV Adopted by the Federal Council
  39. EU IVDR Date of application
  40. CH IvDV Entry into force
  41. EU NIS2 Signed by Parliament and Council
  42. EU EU Pharma Package Commission proposals (COM(2023) 192 Directive and COM(2023) 193 Regulation)
  43. CH DSG Revised act in force
  44. CH TxG/HMG (ATMP) TxG revision adopted by Parliament
  45. CH MepV Transition-period alignment with Reg (EU) 2023/607 in force
  46. EU Data Act Signed by Parliament and Council
  47. CH ISG Entry into force (staged)
  48. EU Data Act Entry into force
  49. CH PatG Patent-procedure revision passed in the final vote
  50. EU AI Act Signed by Parliament and Council
  51. EU SoHO Reg Signed by Parliament and Council
  52. EU AI Act Entry into force
  53. EU SoHO Reg Entry into force
  54. EU NIS2 Member-State transposition deadline
  55. EU CRA Signed by Parliament and Council
  56. EU PLD Signed by Parliament and Council
  57. CH HFG 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
  58. EU PLD Entry into force
  59. EU CRA Entry into force
  60. CH IvDV Transition-alignment amendment in force (mirrors Reg (EU) 2024/1860)
  61. EU HTA Reg Application begins (oncology / ATMPs first)
  62. EU CTR Transition complete: all ongoing trials under the CTR in the Clinical Trials Information System (CTIS)
  63. EU AI Act Prohibitions (Art. 5 AI Act) and AI-literacy duty (Art. 4 AI Act) apply
  64. EU EHDS Signed by Parliament and Council
  65. EU CMA Commission proposal
  66. EU EHDS Entry into force
  67. CH ISG Reporting duty in force: critical-infrastructure operators must report cyberattacks to the Federal Office for Cybersecurity (BACS) within 24 hours of discovery
  68. EU IVDR Deadline to have a quality management system (QMS) under Art. 10(8) IVDR in place, a condition of the extended transition
  69. CH LVG Amendment reorganizing the economic supply organization adopted by Parliament (final vote)
  70. EU GMP Ch. 4 Draft published for consultation
  71. EU GMP Annex 11 Draft published for consultation
  72. EU GMP Annex 22 Draft published for consultation
  73. EU AI Act General-purpose AI (GPAI) model obligations, governance and penalties apply
  74. CH HMG Federal Council dispatch on revision 3a adopted
  75. EU Data Act Main obligations apply
  76. CH ISG Reporting-duty sanctions in force
  77. EU GMP Ch. 4 Consultation closed
  78. EU GMP Annex 11 Consultation closed
  79. EU GMP Annex 22 Consultation closed
  80. CH LVG Amendment in force
  81. CH EPDG Federal Council dispatch on the EGDG (total revision) adopted
  82. EU GDPR Digital Omnibus (data) amendment proposed (COM(2025) 837)
  83. EU EU Pharma Package Provisional agreement between Council and Parliament
  84. EU MDR Targeted MDR/IVDR simplification proposed (COM(2025) 1023)
  85. EU IVDR Targeted MDR/IVDR simplification proposed (COM(2025) 1023)
  86. CH KG Merger-control revision (SIEC test: significant impediment to effective competition) passed in the final vote
  87. CH Bilaterale III Package signed
  88. EU EU Pharma Package Committee of Permanent Representatives (Coreper) confirmed agreement on the final compromise text
  89. CH Bilaterale III Federal Council dispatch (Botschaft) adopted
  90. EU EU Pharma Package Parliament's health committee (SANT) approved the agreed text
  91. CH KG Referendum deadline for the merger-control revision
  92. EU CMA Provisional agreement between Council and Parliament
  93. CH KG Federal Council dispatch on the competition-authorities reform, a second KG bill
  94. EU MDR First four modules of the European database on medical devices (EUDAMED) mandatory (Reg (EU) 2024/1860)
  95. EU CRA Notified-body framework applies (Art. 35–51 CRA)
  96. EU CMA Coreper endorsed the final compromise text
  97. EU GMP Annex 22 European Medicines Agency (EMA) multistakeholder workshop on generative-AI scope
  98. EU CMA Parliament's health committee (SANT) approved the agreed text
  99. EU AI Act Transparency obligations apply (Art. 50 AI Act; not deferred)
  100. EU CRA Reporting obligations (Art. 14 CRA) apply
  101. EU Data Act Access-by-design duty for newly marketed connected products (Art. 3(1) Data Act)
  102. CH KG Implementing-ordinance consultation closed
  103. CH ISG Federal Council mandated a consultation draft, due by June 2027, for a separate cybersecurity act (Cybersicherheitsgesetz, CSG)
  104. EU EU Pharma Package Council adopted its position at first reading; Parliament's second-reading vote and publication remain pending

Updated

Following 12 months, 12 milestones

  1. CH HMG Revision 3b consultation closes
  2. EU EU Pharma Package Parliament plenary vote on the agreed text (indicative)
  3. EU CMA Parliament plenary vote on the agreed text (indicative)
  4. EU AI Act Marking grace period ends for pre-August-2026 generative systems (Art. 50(2) AI Act)
  5. EU AI Act 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)
  6. EU PLD Member-State transposition deadline
  7. CH PatG Revised patent-grant procedure in force
  8. EU EHDS General application; core implementing acts due
  9. EU EHDS 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)
  10. EU AI Act Legacy GPAI models must comply (Art. 111(3) AI Act)
  11. EU SoHO Reg Main obligations apply
  12. EU Data Act Unfair-terms rules extend to pre-existing long-term contracts

2027, 4 milestones

  1. EU AI Act High-risk obligations for Annex III AI Act systems apply (deferred by Reg (EU) 2026/1744)
  2. EU CRA Main obligations apply
  3. EU MDR Legacy transition ends for class III and class IIb implantable devices, except listed IIb implants such as screws and plates (conditional)
  4. EU IVDR Legacy transition ends for all Directive-certified devices and for self-declared class D devices (conditional)

2028, 5 milestones

  1. EU HTA Reg Joint clinical assessment extends to orphan medicinal products
  2. EU AI Act High-risk obligations for Annex I AI Act product-embedded systems apply (deferred by Reg (EU) 2026/1744)
  3. EU SoHO Reg Penalties apply; legacy blood and tissue establishments and their preparations are verified and recorded on the EU SoHO Platform
  4. EU MDR 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)
  5. EU IVDR Legacy transition ends for self-declared class C devices (conditional)

2029 and later, 6 milestones

  1. EU EHDS Primary-use rules apply to the first priority data categories (patient summaries, electronic prescriptions and dispensations); secondary-use rules apply to most data categories
  2. EU IVDR Legacy transition ends for self-declared class B and sterile class A devices (conditional)
  3. EU HTA Reg Joint clinical assessment extends to all other medicinal products in its scope (Art. 7(2)(c) HTA Regulation)
  4. EU IVDR 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)
  5. CH IvDV Health institutions must justify each in-house device by showing that no equivalent device on the market meets the target patient group's needs
  6. EU EHDS 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

Instruments

Medical devices

EU

MDR

In force

Regulation (EU) 2017/745

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.

  • : Signed by Parliament and Council Source
  • : Date of application Source
  • : Targeted MDR/IVDR simplification proposed (COM(2025) 1023) Source
  • : First four modules of the European database on medical devices (EUDAMED) mandatory (Reg (EU) 2024/1860) Source
  • : Legacy transition ends for class III and class IIb implantable devices, except listed IIb implants such as screws and plates (conditional) Source
  • : 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) Source
Official text

Bilaterale III (Mutual Recognition Agreement update)

CH

Bilaterale III

Upcoming

BBl 2026 615 (Federal Council dispatch, Geschäft 26.023); signed 2 March 2026, ratification pending

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.

  • : Package signed Source
  • : Federal Council dispatch (Botschaft) adopted Source
Official text

In-vitro diagnostics

EU

IVDR

Phasing in

Regulation (EU) 2017/746

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.

  • : Signed by Parliament and Council Source
  • : Date of application Source
  • : Deadline to have a quality management system (QMS) under Art. 10(8) IVDR in place, a condition of the extended transition Source
  • : Targeted MDR/IVDR simplification proposed (COM(2025) 1023) Source
  • : Legacy transition ends for all Directive-certified devices and for self-declared class D devices (conditional) Source
  • : Legacy transition ends for self-declared class C devices (conditional) Source
  • : Legacy transition ends for self-declared class B and sterile class A devices (conditional) Source
  • : 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) Source
Official text
CH

IvDV

Phasing in

SR 812.219

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.

  • : Adopted by the Federal Council Source
  • : Entry into force Source
  • : Transition-alignment amendment in force (mirrors Reg (EU) 2024/1860) Source
  • : Health institutions must justify each in-house device by showing that no equivalent device on the market meets the target patient group's needs Source
Official text

Data protection

EU

GDPR

In force

Regulation (EU) 2016/679

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.

  • : Signed by Parliament and Council Source
  • : Date of application Source
  • : Digital Omnibus (data) amendment proposed (COM(2025) 837) Source
Official text

Health data

EU

EHDS

Upcoming

Regulation (EU) 2025/327

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.

  • : Signed by Parliament and Council Source
  • : Entry into force Source
  • : General application; core implementing acts due Source
  • : 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) Source
  • : Primary-use rules apply to the first priority data categories (patient summaries, electronic prescriptions and dispensations); secondary-use rules apply to most data categories Source
  • : 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 Source
Official text
CH

EPDG

In force

SR 816.1

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.

  • : Adopted by Parliament (final vote) Source
  • : Entry into force Source
  • : Federal Council dispatch on the EGDG (total revision) adopted Source
Official text

Data Act (connected products and cloud)

EU

Data Act

Phasing in

Regulation (EU) 2023/2854

EU horizontal rules on access to connected-product data, business-to-business data sharing, and cloud switching.

  • : Signed by Parliament and Council Source
  • : Entry into force Source
  • : Main obligations apply Source
  • : Access-by-design duty for newly marketed connected products (Art. 3(1) Data Act) Source
  • : Unfair-terms rules extend to pre-existing long-term contracts Source
Official text
CH

No direct Swiss equivalent yet.

Network and information security

EU

NIS2

Phasing in

Directive (EU) 2022/2555

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).

  • : Signed by Parliament and Council Source
  • : Member-State transposition deadline Source
Official text
CH

ISG

In force

SR 128

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.

  • : Adopted by Parliament (final vote) Source
  • : Entry into force (staged) Source
  • : Reporting duty in force: critical-infrastructure operators must report cyberattacks to the Federal Office for Cybersecurity (BACS) within 24 hours of discovery Source
  • : Reporting-duty sanctions in force Source
  • : Federal Council mandated a consultation draft, due by June 2027, for a separate cybersecurity act (Cybersicherheitsgesetz, CSG) Source
Official text

Product cyber resilience

EU

CRA

Phasing in

Regulation (EU) 2024/2847

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.

  • : Signed by Parliament and Council Source
  • : Entry into force Source
  • : Notified-body framework applies (Art. 35–51 CRA) Source
  • : Reporting obligations (Art. 14 CRA) apply Source
  • : Main obligations apply Source
Official text
CH

No direct Swiss equivalent yet.

Artificial intelligence

EU

AI Act

Phasing in

Regulation (EU) 2024/1689

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.

  • : Signed by Parliament and Council Source
  • : Entry into force Source
  • : Prohibitions (Art. 5 AI Act) and AI-literacy duty (Art. 4 AI Act) apply Source
  • : General-purpose AI (GPAI) model obligations, governance and penalties apply Source
  • : Transparency obligations apply (Art. 50 AI Act; not deferred) Source
  • : Marking grace period ends for pre-August-2026 generative systems (Art. 50(2) AI Act) Source
  • : 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) Source
  • : Legacy GPAI models must comply (Art. 111(3) AI Act) Source
  • : High-risk obligations for Annex III AI Act systems apply (deferred by Reg (EU) 2026/1744) Source
  • : High-risk obligations for Annex I AI Act product-embedded systems apply (deferred by Reg (EU) 2026/1744) Source
Official text
CH

No direct Swiss equivalent yet.

Clinical trials

EU

CTR

In force

Regulation (EU) No 536/2014

EU regulation harmonizing clinical trial authorization and supervision through the Clinical Trials Information System (CTIS). The EU Pharma Package, once adopted, would amend it.

  • : Signed by Parliament and Council Source
  • : Date of application Source
  • : Transition complete: all ongoing trials under the CTR in the Clinical Trials Information System (CTIS) Source
Official text
CH

HFG

In force

SR 810.30

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.

  • : Adopted by Parliament (final vote) Source
  • : Entry into force Source
  • : 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 Source
Official text

Medicinal products

EU

EU Pharma Package

Upcoming

Council first-reading positions ST-7105/26 (Regulation) and ST-7106/26 (Directive)

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.

  • : Commission proposals (COM(2023) 192 Directive and COM(2023) 193 Regulation) Source
  • : Provisional agreement between Council and Parliament Source
  • : Committee of Permanent Representatives (Coreper) confirmed agreement on the final compromise text Source
  • : Parliament's health committee (SANT) approved the agreed text Source
  • : Council adopted its position at first reading; Parliament's second-reading vote and publication remain pending Source
  • : Parliament plenary vote on the agreed text (indicative) Source
Official text: Council position (Regulation) Official text: Council position (Directive)
CH

HMG

In force

SR 812.21

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.

  • : Adopted by Parliament (final vote) Source
  • : Federal Council dispatch on revision 3a adopted Source
  • : Revision 3b consultation closes Source
Official text

Critical medicines and supply security

EU

CMA

Upcoming

COM(2025) 102 (Commission proposal); final compromise text ST-11059/26

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.

  • : Commission proposal Source
  • : Provisional agreement between Council and Parliament Source
  • : Coreper endorsed the final compromise text Source
  • : Parliament's health committee (SANT) approved the agreed text Source
  • : Parliament plenary vote on the agreed text (indicative) Source
CH

LVG

In force

SR 531

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.

  • : Adopted by Parliament (final vote) Source
  • : Totally revised LVG in force Source
  • : Amendment reorganizing the economic supply organization adopted by Parliament (final vote) Source
  • : Amendment in force Source
Official text

Good manufacturing practice (GMP) guidelines (EudraLex Volume 4)

EU

GMP Ch. 4

Proposed

EudraLex Volume 4, Chapter 4 (Documentation)

Revised GMP documentation chapter; risk-management and data-governance principles, draft under finalization.

  • : Draft published for consultation Source
  • : Consultation closed Source
Official text
EU

GMP Annex 22

Proposed

EudraLex Volume 4, Annex 22 (Artificial Intelligence)

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.

  • : Draft published for consultation Source
  • : Consultation closed Source
  • : European Medicines Agency (EMA) multistakeholder workshop on generative-AI scope Source
Official text
CH

AMBV

In force

AMBV (SR 812.212.1); PIC/S GMP Guide

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).

  • : Adopted by the Federal Council Source
Official text

Product liability

EU

PLD

Upcoming

Directive (EU) 2024/2853

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.

  • : Signed by Parliament and Council Source
  • : Entry into force Source
  • : Member-State transposition deadline Source
Official text

Supplementary protection certificates

Advanced therapy medicinal products

CH

TxG/HMG (ATMP)

In force

SR 810.21; SR 812.21

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.

  • : TxG adopted by Parliament (final vote) Source
  • : TxG entry into force Source
  • : TxG revision adopted by Parliament Source
Official text: TxG Official text: HMG

Substances of human origin

EU

SoHO Reg

Upcoming

Regulation (EU) 2024/1938

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.

  • : Signed by Parliament and Council Source
  • : Entry into force Source
  • : Main obligations apply Source
  • : Penalties apply; legacy blood and tissue establishments and their preparations are verified and recorded on the EU SoHO Platform Source
Official text
CH

HMG/TxG (SoHO)

In force

SR 812.21; SR 810.21

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.

  • : TxG adopted by Parliament (final vote) Source
Official text: TxG Official text: HMG

Health technology assessment

EU

HTA Reg

Phasing in

Regulation (EU) 2021/2282

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.

  • : Signed by Parliament and Council Source
  • : Application begins (oncology / ATMPs first) Source
  • : Joint clinical assessment extends to orphan medicinal products Source
  • : Joint clinical assessment extends to all other medicinal products in its scope (Art. 7(2)(c) HTA Regulation) Source
Official text
CH

No direct Swiss equivalent yet.

Orphan medicinal products

CH

HMG (Orphan)

In force

Art. 4 Abs. 1 Bst. adecies, Art. 14 Abs. 1 Bst. f, Art. 11b Abs. 4 HMG (SR 812.21)

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.

  • : Orphan-drug provisions adopted by Parliament (HMG amendment, final vote) Source
  • : Revised HMG orphan provisions in force Source
Official text

Pediatric medicines

EU

Pediatric Reg

In force

Regulation (EC) No 1901/2006

EU framework on medicines for pediatric use. The EU Pharma Package, once adopted and applicable, would repeal it and absorb its rules.

  • : Signed by Parliament and Council Source
Official text
CH

HMG/PatG

In force

Art. 54a ff. HMG; Art. 140n and 140t PatG

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.

  • : Pediatric provisions adopted by Parliament (HMG and PatG amendment, final vote) Source
  • : Pediatric provisions of the revised HMG and PatG in force Source
Official text: HMG Official text: PatG

Patent-grant procedure

CH

PatG

In force

SR 232.14; amendment of 15 March 2024 (AS 2026 232)

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).

  • : Adopted by Parliament (final vote) Source
  • : Patent-procedure revision passed in the final vote Source
  • : Revised patent-grant procedure in force Source
Official text

Competition and merger control

CH

KG

In force

SR 251

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.

  • : Adopted by Parliament (final vote) Source
  • : Merger-control revision (SIEC test: significant impediment to effective competition) passed in the final vote Source
  • : Referendum deadline for the merger-control revision Source
  • : Federal Council dispatch on the competition-authorities reform, a second KG bill Source
  • : Implementing-ordinance consultation closed Source
Official text

This tracker provides general information and is not legal advice. Dates and legal status may change; check the current position before relying on an entry.

Cite as: Rechtsanwalt Dr. iur. Claus Gawel, LLM, Regulatory tracker (gawel.ch/regulatory-tracker/)

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