§ 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 States
Authority & dossier
Regulatory authority	Swissmedic	FDA
English submissions	Yes	Yes
CTD accepted	Yes	Yes
eCTD accepted	Yes	Yes
Reliance pathway	Available	None
Reference agencies	FDA, EMA, MHRA, Health Canada +2	—
Lead pathway (timeline & fees) — Standard Authorisation Procedure · New Drug Application — 505(b)(1)
Pathway name	Standard Authorisation Procedure	New Drug Application — 505(b)(1)
Approval timeline	330–365 days	304–365 days
Application fee	CHF 100,000	USD 4,310,002
Annual renewal	CHF 5,500	USD 416,734
Local representative	Required	Not required
Local manufacturing	Not required	Not required
GMP inspection	Required	Required
MAH & local presence
Local entity required	Yes	No
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.	US Agent: a person residing or maintaining a place of business in the US, designated to act on behalf of the foreign establishment for FDA communications, including notification of inspections.
Accelerated pathways
Designations available	4 designations	6 designations
Examples	Fast-Track Authorisation Procedure, Orphan Drug Designation, Temporary Authorisation (Art. 9a HMG) +1	Priority Review, Breakthrough Therapy Designation, Accelerated Approval — Subpart H/E +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.	FDA classifies post-approval changes as: Annual Reportable, Changes Being Effected (CBE-0 immediate, CBE-30 with 30-day pre-implementation notice), and Prior Approval Supplements (PAS) — the most significant changes requiring FDA approval before implementation. Major manufacturing or labelling changes typically require a PAS.
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).	FDA does not require periodic renewal of NDAs or BLAs — approvals remain in effect indefinitely subject to compliance, payment of annual program fees, and post-marketing requirements. Annual reports are required.
Pharmacovigilance	PSUR (PBRER) submission aligned with EU schedules; MAH must designate a Swiss QPPV-equivalent. Adverse drug reaction reporting via the ElViS electronic system.	Mandatory expedited reporting of serious unexpected ADRs within 15 calendar days; periodic safety reports (PADERs/PAERs) for the first 3 years post-approval, then annually. PSURs in ICH E2C(R2) format accepted in lieu of PADERs by agreement. FAERS database receives spontaneous reports. Post-Marketing Requirements (PMRs) and Commitments (PMCs) tracked publicly.
Unlicensed access
Named Patient Supply	Available	Available
Compassionate Use	Available	Available
Emergency Import	Available	Available
Parallel Import	Permitted	Not permitted
Clinical trials
CTA approval	Required	Required
Ethics approval	Yes	Yes
CTA timeline	30–60 days	30–30 days
GCP standard	ICH-GCP E6(R3)	ICH E6(R3) (adopted via FDA guidance January 2025); 21 CFR 312, 314, 50, 56
Pricing & reimbursement
Price regulation	Regulated	Free pricing
Reference pricing	Yes	No
HTA required	Yes	No
HTA body	Federal Office of Public Health (FOPH/BAG) — Speciality List unit	ICER (Institute for Clinical and Economic Review) — independent, non-binding

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

Authority & dossier

Regulatory authority

SwitzerlandSwissmedic
United StatesFDA

English submissions

SwitzerlandYes
United StatesYes

CTD accepted

SwitzerlandYes
United StatesYes

eCTD accepted

SwitzerlandYes
United StatesYes

Reliance pathway

SwitzerlandAvailable
United StatesNone

Reference agencies

SwitzerlandFDA, EMA, MHRA, Health Canada +2
United States—

Lead pathway (timeline & fees) — Standard Authorisation Procedure · New Drug Application — 505(b)(1)

Pathway name

SwitzerlandStandard Authorisation Procedure
United StatesNew Drug Application — 505(b)(1)

Approval timeline

Switzerland330–365 days
United States304–365 days

Application fee

SwitzerlandCHF 100,000
United StatesUSD 4,310,002

Annual renewal

SwitzerlandCHF 5,500
United StatesUSD 416,734

Local representative

SwitzerlandRequired
United StatesNot required

Local manufacturing

SwitzerlandNot required
United StatesNot required

GMP inspection

SwitzerlandRequired
United StatesRequired

MAH & local presence

Local entity required

SwitzerlandYes
United StatesNo

Local responsible person

SwitzerlandYes
United StatesYes

RP role

SwitzerlandFachtechnisch verantwortliche Person (FvP / responsable technique): Swiss-based qualified person responsible for compliance with the HMG, batch release, and pharmacovigilance contact.
United StatesUS Agent: a person residing or maintaining a place of business in the US, designated to act on behalf of the foreign establishment for FDA communications, including notification of inspections.

Accelerated pathways

Designations available

Switzerland4 designations
United States6 designations

Examples

SwitzerlandFast-Track Authorisation Procedure, Orphan Drug Designation, Temporary Authorisation (Art. 9a HMG) +1
United StatesPriority Review, Breakthrough Therapy Designation, Accelerated Approval — Subpart H/E +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.
United StatesFDA classifies post-approval changes as: Annual Reportable, Changes Being Effected (CBE-0 immediate, CBE-30 with 30-day pre-implementation notice), and Prior Approval Supplements (PAS) — the most significant changes requiring FDA approval before implementation. Major manufacturing or labelling changes typically require a PAS.

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 StatesFDA does not require periodic renewal of NDAs or BLAs — approvals remain in effect indefinitely subject to compliance, payment of annual program fees, and post-marketing requirements. Annual reports are required.

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 StatesMandatory expedited reporting of serious unexpected ADRs within 15 calendar days; periodic safety reports (PADERs/PAERs) for the first 3 years post-approval, then annually. PSURs in ICH E2C(R2) format accepted in lieu of PADERs by agreement. FAERS database receives spontaneous reports. Post-Marketing Requirements (PMRs) and Commitments (PMCs) tracked publicly.

Unlicensed access

Named Patient Supply

SwitzerlandAvailable
United StatesAvailable

Compassionate Use

SwitzerlandAvailable
United StatesAvailable

Emergency Import

SwitzerlandAvailable
United StatesAvailable

Parallel Import

SwitzerlandPermitted
United StatesNot permitted

Clinical trials

CTA approval

SwitzerlandRequired
United StatesRequired

Ethics approval

SwitzerlandYes
United StatesYes

CTA timeline

Switzerland30–60 days
United States30–30 days

GCP standard

SwitzerlandICH-GCP E6(R3)
United StatesICH E6(R3) (adopted via FDA guidance January 2025); 21 CFR 312, 314, 50, 56

Pricing & reimbursement

Price regulation

SwitzerlandRegulated
United StatesFree pricing

Reference pricing

SwitzerlandYes
United StatesNo

HTA required

SwitzerlandYes
United StatesNo

HTA body

SwitzerlandFederal Office of Public Health (FOPH/BAG) — Speciality List unit
United StatesICER (Institute for Clinical and Economic Review) — independent, non-binding