§ 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	🇬🇧United Kingdom
Authority & dossier
Regulatory authority	Swissmedic	MHRA
English submissions	Yes	Yes
CTD accepted	Yes	Yes
eCTD accepted	Yes	Yes
Reliance pathway	Available	Available
Reference agencies	FDA, EMA, MHRA, Health Canada +2	FDA, EMA, Health Canada, Swissmedic +4
Lead pathway (timeline & fees) — Standard Authorisation Procedure · International Recognition Procedure (IRP)
Pathway name	Standard Authorisation Procedure	International Recognition Procedure (IRP)
Approval timeline	330–365 days	60–110 days
Application fee	CHF 100,000	GBP 35,305
Annual renewal	CHF 5,500	GBP 0
Local representative	Required	Not required
Local manufacturing	Not required	Not required
GMP inspection	Required	Not 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 (Pharmacovigilance) — QPPV — must reside in the UK or EEA. UK Responsible Person (Import) for batch certification of products imported into GB. Local pharmacovigilance contact in the UK required for risk minimisation activities.
Accelerated pathways
Designations available	4 designations	4 designations
Examples	Fast-Track Authorisation Procedure, Orphan Drug Designation, Temporary Authorisation (Art. 9a HMG) +1	Early Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1
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.	Variations classified per UK Variations Regulations (mirroring EU Reg 1234/2008): Type IA, IAIN, IB, II, and Extensions. MHRA Worksharing available for grouped 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; thereafter MA is granted for unlimited duration unless MHRA determines on PV grounds that one further 5-year renewal is justified.
Pharmacovigilance	PSUR (PBRER) submission aligned with EU schedules; MAH must designate a Swiss QPPV-equivalent. Adverse drug reaction reporting via the ElViS electronic system.	MHRA operates the Yellow Card Scheme for ADR reporting. PSURs follow the EU Reference Date list pre-Brexit, with MHRA UK-specific PSUR list since 2021. RMPs required for new MAs and significant variations. Black triangle (▼) for additional monitoring.
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	30–60 days
GCP standard	ICH-GCP E6(R3)	ICH E6(R3) (MHRA adopted via Good Clinical Practice Guide; UK statutory instruments 2004/1031 as amended)
Pricing & reimbursement
Price regulation	Regulated	Regulated
Reference pricing	Yes	No
HTA required	Yes	Yes
HTA body	Federal Office of Public Health (FOPH/BAG) — Speciality List unit	NICE (England, Wales, NI), SMC (Scotland), AWMSG (Wales)

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

Authority & dossier

Regulatory authority

SwitzerlandSwissmedic
United KingdomMHRA

English submissions

SwitzerlandYes
United KingdomYes

CTD accepted

SwitzerlandYes
United KingdomYes

eCTD accepted

SwitzerlandYes
United KingdomYes

Reliance pathway

SwitzerlandAvailable
United KingdomAvailable

Reference agencies

SwitzerlandFDA, EMA, MHRA, Health Canada +2
United KingdomFDA, EMA, Health Canada, Swissmedic +4

Lead pathway (timeline & fees) — Standard Authorisation Procedure · International Recognition Procedure (IRP)

Pathway name

SwitzerlandStandard Authorisation Procedure
United KingdomInternational Recognition Procedure (IRP)

Approval timeline

Switzerland330–365 days
United Kingdom60–110 days

Application fee

SwitzerlandCHF 100,000
United KingdomGBP 35,305

Annual renewal

SwitzerlandCHF 5,500
United KingdomGBP 0

Local representative

SwitzerlandRequired
United KingdomNot required

Local manufacturing

SwitzerlandNot required
United KingdomNot required

GMP inspection

SwitzerlandRequired
United KingdomNot required

MAH & local presence

Local entity required

SwitzerlandYes
United KingdomYes

Local responsible person

SwitzerlandYes
United KingdomYes

RP role

SwitzerlandFachtechnisch verantwortliche Person (FvP / responsable technique): Swiss-based qualified person responsible for compliance with the HMG, batch release, and pharmacovigilance contact.
United KingdomQualified Person (Pharmacovigilance) — QPPV — must reside in the UK or EEA. UK Responsible Person (Import) for batch certification of products imported into GB. Local pharmacovigilance contact in the UK required for risk minimisation activities.

Accelerated pathways

Designations available

Switzerland4 designations
United Kingdom4 designations

Examples

SwitzerlandFast-Track Authorisation Procedure, Orphan Drug Designation, Temporary Authorisation (Art. 9a HMG) +1
United KingdomEarly Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1

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.
United KingdomVariations classified per UK Variations Regulations (mirroring EU Reg 1234/2008): Type IA, IAIN, IB, II, and Extensions. MHRA Worksharing available for grouped 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).
United KingdomInitial 5-year renewal; thereafter MA is granted for unlimited duration unless MHRA determines on PV grounds that one further 5-year renewal is justified.

Pharmacovigilance

SwitzerlandPSUR (PBRER) submission aligned with EU schedules; MAH must designate a Swiss QPPV-equivalent. Adverse drug reaction reporting via the ElViS electronic system.
United KingdomMHRA operates the Yellow Card Scheme for ADR reporting. PSURs follow the EU Reference Date list pre-Brexit, with MHRA UK-specific PSUR list since 2021. RMPs required for new MAs and significant variations. Black triangle (▼) for additional monitoring.

Unlicensed access

Named Patient Supply

SwitzerlandAvailable
United KingdomAvailable

Compassionate Use

SwitzerlandAvailable
United KingdomAvailable

Emergency Import

SwitzerlandAvailable
United KingdomAvailable

Parallel Import

SwitzerlandPermitted
United KingdomPermitted

Clinical trials

CTA approval

SwitzerlandRequired
United KingdomRequired

Ethics approval

SwitzerlandYes
United KingdomYes

CTA timeline

Switzerland30–60 days
United Kingdom30–60 days

GCP standard

SwitzerlandICH-GCP E6(R3)
United KingdomICH E6(R3) (MHRA adopted via Good Clinical Practice Guide; UK statutory instruments 2004/1031 as amended)

Pricing & reimbursement

Price regulation

SwitzerlandRegulated
United KingdomRegulated

Reference pricing

SwitzerlandYes
United KingdomNo

HTA required

SwitzerlandYes
United KingdomYes

HTA body

SwitzerlandFederal Office of Public Health (FOPH/BAG) — Speciality List unit
United KingdomNICE (England, Wales, NI), SMC (Scotland), AWMSG (Wales)