§ 02 — Comparison

Compare regulatory pathways side-by-side

Benchmark MAHMAH, GMPGMP, HTAHTA and pathway requirements across up to three markets.

Country A

Country B

Country C

Highlight differences

Criterion	🇨🇭Switzerland	🇪🇺European Union
Authority & dossier
Regulatory authority	Swissmedic	EMA
English submissions	Yes	Yes
CTD accepted	Yes	Yes
eCTD accepted	Yes	Yes
Reliance pathway	Available	Available
Reference agencies	FDA, EMA, MHRA, Health Canada +2	—
Lead pathway (timeline & fees) — Standard Authorisation Procedure · Centralised Procedure
Pathway name	Standard Authorisation Procedure	Centralised Procedure
Approval timeline	330–365 days	210–277 days
Application fee	CHF 100,000	EUR 358,800
Annual renewal	CHF 5,500	EUR 122,500
Local representative	Required	Required
Local manufacturing	Not required	Not required
GMP inspection	Required	Required
MAH & local presence
Local entity required	Yes	Yes
Local responsible person	Yes	Yes
RP role	Fachtechnisch verantwortliche Person (FvP / responsable technique): Swiss-based qualified person responsible for compliance with the HMG, batch release, and pharmacovigilance contact.	Qualified Person Responsible for Pharmacovigilance (QPPV) — must reside and operate in the EU/EEA — is responsible for the establishment and maintenance of the pharmacovigilance system. A Qualified Person (QP) in the EU/EEA performs batch certification under Article 51 of Directive 2001/83/EC. Local Contact Person for pharmacovigilance required in each Member State where the product is marketed (since 2012 GVP).
Accelerated pathways
Designations available	4 designations	6 designations
Examples	Fast-Track Authorisation Procedure, Orphan Drug Designation, Temporary Authorisation (Art. 9a HMG) +1	Accelerated Assessment, Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +3
Post-approval lifecycle
Variations framework	Variations classified as Type IA, IA(IN), IB, II following the EU classification, adapted for Swiss specifics. Renewals and grouped variations supported.	Commission Regulation (EC) 1234/2008 establishes four categories: Type IA (minor — Do and Tell, 12-month notification), Type IAIN (minor — immediate notification), Type IB (minor — Tell, Wait, and Do, 30-day default), Type II (major — prior approval, 60–90 days), and Extensions (Annex I changes — full review). Worksharing procedures consolidate variations across multiple authorisations.
Renewal cycle	First renewal at 5 years; subsequent renewals every 5 years (some products eligible for unlimited validity after first renewal under Art. 16 HMG, since the 2019 OAMéd revision).	Initial 5-year renewal — application 9 months before expiry. After the first renewal, MA is granted for unlimited duration unless the CHMP/NCA, on justified grounds relating to pharmacovigilance, decides on one additional 5-year renewal.
Pharmacovigilance	PSUR (PBRER) submission aligned with EU schedules; MAH must designate a Swiss QPPV-equivalent. Adverse drug reaction reporting via the ElViS electronic system.	Comprehensive PV framework under Directive 2010/84/EU and Regulation (EU) 1235/2010, codified in Good Pharmacovigilance Practices (GVP). Pharmacovigilance System Master File (PSMF) required. Periodic Safety Update Reports (PSURs) on EU-harmonised birth-date list. Risk Management Plans for all new MAs and significant variations. Suspected serious ADR reporting to EudraVigilance within 15 days. Black triangle (▼) for additional monitoring of selected products.
Unlicensed access
Named Patient Supply	Available	Available
Compassionate Use	Available	Available
Emergency Import	Available	Available
Parallel Import	Permitted	Permitted
Clinical trials
CTA approval	Required	Required
Ethics approval	Yes	Yes
CTA timeline	30–60 days	60–106 days
GCP standard	ICH-GCP E6(R3)	ICH E6(R3) — Commission Regulation (EU) 2024/2748 transposing R3, applicable from 23 July 2025
Pricing & reimbursement
Price regulation	Regulated	Regulated
Reference pricing	Yes	Yes
HTA required	Yes	Yes
HTA body	Federal Office of Public Health (FOPH/BAG) — Speciality List unit	EU HTA Coordination Group (EUnetHTA legacy); national HTA bodies (NICE, HAS, G-BA/IQWiG, AIFA, AEMPS, etc.)

Verdict colours indicate lower, moderate, or higher regulatory burden — they're not value judgements on a market.

Authority & dossier

Regulatory authority

SwitzerlandSwissmedic
European UnionEMA

English submissions

SwitzerlandYes
European UnionYes

CTD accepted

SwitzerlandYes
European UnionYes

eCTD accepted

SwitzerlandYes
European UnionYes

Reliance pathway

SwitzerlandAvailable
European UnionAvailable

Reference agencies

SwitzerlandFDA, EMA, MHRA, Health Canada +2
European Union—

Lead pathway (timeline & fees) — Standard Authorisation Procedure · Centralised Procedure

Pathway name

SwitzerlandStandard Authorisation Procedure
European UnionCentralised Procedure

Approval timeline

Switzerland330–365 days
European Union210–277 days

Application fee

SwitzerlandCHF 100,000
European UnionEUR 358,800

Annual renewal

SwitzerlandCHF 5,500
European UnionEUR 122,500

Local representative

SwitzerlandRequired
European UnionRequired

Local manufacturing

SwitzerlandNot required
European UnionNot required

GMP inspection

SwitzerlandRequired
European UnionRequired

MAH & local presence

Local entity required

SwitzerlandYes
European UnionYes

Local responsible person

SwitzerlandYes
European UnionYes

RP role

SwitzerlandFachtechnisch verantwortliche Person (FvP / responsable technique): Swiss-based qualified person responsible for compliance with the HMG, batch release, and pharmacovigilance contact.
European UnionQualified Person Responsible for Pharmacovigilance (QPPV) — must reside and operate in the EU/EEA — is responsible for the establishment and maintenance of the pharmacovigilance system. A Qualified Person (QP) in the EU/EEA performs batch certification under Article 51 of Directive 2001/83/EC. Local Contact Person for pharmacovigilance required in each Member State where the product is marketed (since 2012 GVP).

Accelerated pathways

Designations available

Switzerland4 designations
European Union6 designations

Examples

SwitzerlandFast-Track Authorisation Procedure, Orphan Drug Designation, Temporary Authorisation (Art. 9a HMG) +1
European UnionAccelerated Assessment, Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +3

Post-approval lifecycle

Variations framework

SwitzerlandVariations classified as Type IA, IA(IN), IB, II following the EU classification, adapted for Swiss specifics. Renewals and grouped variations supported.
European UnionCommission Regulation (EC) 1234/2008 establishes four categories: Type IA (minor — Do and Tell, 12-month notification), Type IAIN (minor — immediate notification), Type IB (minor — Tell, Wait, and Do, 30-day default), Type II (major — prior approval, 60–90 days), and Extensions (Annex I changes — full review). Worksharing procedures consolidate variations across multiple authorisations.

Renewal cycle

SwitzerlandFirst renewal at 5 years; subsequent renewals every 5 years (some products eligible for unlimited validity after first renewal under Art. 16 HMG, since the 2019 OAMéd revision).
European UnionInitial 5-year renewal — application 9 months before expiry. After the first renewal, MA is granted for unlimited duration unless the CHMP/NCA, on justified grounds relating to pharmacovigilance, decides on one additional 5-year renewal.

Pharmacovigilance

SwitzerlandPSUR (PBRER) submission aligned with EU schedules; MAH must designate a Swiss QPPV-equivalent. Adverse drug reaction reporting via the ElViS electronic system.
European UnionComprehensive PV framework under Directive 2010/84/EU and Regulation (EU) 1235/2010, codified in Good Pharmacovigilance Practices (GVP). Pharmacovigilance System Master File (PSMF) required. Periodic Safety Update Reports (PSURs) on EU-harmonised birth-date list. Risk Management Plans for all new MAs and significant variations. Suspected serious ADR reporting to EudraVigilance within 15 days. Black triangle (▼) for additional monitoring of selected products.

Unlicensed access

Named Patient Supply

SwitzerlandAvailable
European UnionAvailable

Compassionate Use

SwitzerlandAvailable
European UnionAvailable

Emergency Import

SwitzerlandAvailable
European UnionAvailable

Parallel Import

SwitzerlandPermitted
European UnionPermitted

Clinical trials

CTA approval

SwitzerlandRequired
European UnionRequired

Ethics approval

SwitzerlandYes
European UnionYes

CTA timeline

Switzerland30–60 days
European Union60–106 days

GCP standard

SwitzerlandICH-GCP E6(R3)
European UnionICH E6(R3) — Commission Regulation (EU) 2024/2748 transposing R3, applicable from 23 July 2025

Pricing & reimbursement

Price regulation

SwitzerlandRegulated
European UnionRegulated

Reference pricing

SwitzerlandYes
European UnionYes

HTA required

SwitzerlandYes
European UnionYes

HTA body

SwitzerlandFederal Office of Public Health (FOPH/BAG) — Speciality List unit
European UnionEU HTA Coordination Group (EUnetHTA legacy); national HTA bodies (NICE, HAS, G-BA/IQWiG, AIFA, AEMPS, etc.)