§ 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	🇨🇳China	🇺🇸United States	🇪🇺European Union
Authority & dossier
Regulatory authority	NMPA	FDA	EMA
English submissions	No	Yes	Yes
CTD accepted	Yes	Yes	Yes
eCTD accepted	Yes	Yes	Yes
Reliance pathway	None	None	Available
Reference agencies	FDA, EMA, MHRA, PMDA +2	—	—
Lead pathway (timeline & fees) — New Drug Application (Class 1) — Innovative Drug · New Drug Application — 505(b)(1) · Centralised Procedure
Pathway name	New Drug Application (Class 1) — Innovative Drug	New Drug Application — 505(b)(1)	Centralised Procedure
Approval timeline	200–365 days	304–365 days	210–277 days
Application fee	CNY 622,500	USD 4,310,002	EUR 358,800
Annual renewal	CNY 23,800	USD 416,734	EUR 122,500
Local representative	Required	Not required	Required
Local manufacturing	Not required	Not required	Not required
GMP inspection	Required	Required	Required
MAH & local presence
Local entity required	No	No	Yes
Local responsible person	Yes	Yes	Yes
RP role	Authorised Agent (境内代理人): Chinese-incorporated entity responsible for NMPA communications, pharmacovigilance reporting, recall coordination, and pharmacovigilance system master file maintenance. The MAH must also appoint a qualified person for pharmacovigilance and a qualified person for quality.	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.	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	5 designations	6 designations	6 designations
Examples	Breakthrough Therapy Designation (突破性治疗药物), Priority Review (优先审评), Conditional Approval (附条件批准) +2	Priority Review, Breakthrough Therapy Designation, Accelerated Approval — Subpart H/E +3	Accelerated Assessment, Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +3
Post-approval lifecycle
Variations framework	Post-approval changes classified as Major (重大), Moderate (中等), and Minor (微小) variations, broadly aligned with ICH Q12 principles but with China-specific procedures published in the 2021 NMPA Guideline on Post-Approval Changes.	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.	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	Marketing authorisations are valid for 5 years with mandatory renewal. Renewal application due ≥6 months before expiry; renewal review can take 90–180 working days.	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.	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	Pharmacovigilance system aligned with ICH E2D/E2E since the 2021 Good Pharmacovigilance Practice (GVP) for Drugs entered force. PSURs follow ICH E2C(R2). MAH must establish a pharmacovigilance system, appoint a qualified person for pharmacovigilance (PV-QP), and report to the National Center for ADR Monitoring.	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.	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	Available
Compassionate Use	Available	Available	Available
Emergency Import	Available	Available	Available
Parallel Import	Not permitted	Not permitted	Permitted
Clinical trials
CTA approval	Required	Required	Required
Ethics approval	Yes	Yes	Yes
CTA timeline	60–90 days	30–30 days	60–106 days
GCP standard	Chinese GCP (2020 revision, ICH E6(R2) aligned)	ICH E6(R3) (adopted via FDA guidance January 2025); 21 CFR 312, 314, 50, 56	ICH E6(R3) — Commission Regulation (EU) 2024/2748 transposing R3, applicable from 23 July 2025
Pricing & reimbursement
Price regulation	Regulated	Free pricing	Regulated
Reference pricing	No	No	Yes
HTA required	Yes	No	Yes
HTA body	National Healthcare Security Administration (NHSA) — Centre for Medical Service Information	ICER (Institute for Clinical and Economic Review) — independent, non-binding	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

ChinaNMPA
United StatesFDA
European UnionEMA

English submissions

ChinaNo
United StatesYes
European UnionYes

CTD accepted

ChinaYes
United StatesYes
European UnionYes

eCTD accepted

ChinaYes
United StatesYes
European UnionYes

Reliance pathway

ChinaNone
United StatesNone
European UnionAvailable

Reference agencies

ChinaFDA, EMA, MHRA, PMDA +2
United States—
European Union—

Lead pathway (timeline & fees) — New Drug Application (Class 1) — Innovative Drug · New Drug Application — 505(b)(1) · Centralised Procedure

Pathway name

ChinaNew Drug Application (Class 1) — Innovative Drug
United StatesNew Drug Application — 505(b)(1)
European UnionCentralised Procedure

Approval timeline

China200–365 days
United States304–365 days
European Union210–277 days

Application fee

ChinaCNY 622,500
United StatesUSD 4,310,002
European UnionEUR 358,800

Annual renewal

ChinaCNY 23,800
United StatesUSD 416,734
European UnionEUR 122,500

Local representative

ChinaRequired
United StatesNot required
European UnionRequired

Local manufacturing

ChinaNot required
United StatesNot required
European UnionNot required

GMP inspection

ChinaRequired
United StatesRequired
European UnionRequired

MAH & local presence

Local entity required

ChinaNo
United StatesNo
European UnionYes

Local responsible person

ChinaYes
United StatesYes
European UnionYes

RP role

ChinaAuthorised Agent (境内代理人): Chinese-incorporated entity responsible for NMPA communications, pharmacovigilance reporting, recall coordination, and pharmacovigilance system master file maintenance. The MAH must also appoint a qualified person for pharmacovigilance and a qualified person for quality.
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.
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

China5 designations
United States6 designations
European Union6 designations

Examples

ChinaBreakthrough Therapy Designation (突破性治疗药物), Priority Review (优先审评), Conditional Approval (附条件批准) +2
United StatesPriority Review, Breakthrough Therapy Designation, Accelerated Approval — Subpart H/E +3
European UnionAccelerated Assessment, Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +3

Post-approval lifecycle

Variations framework

ChinaPost-approval changes classified as Major (重大), Moderate (中等), and Minor (微小) variations, broadly aligned with ICH Q12 principles but with China-specific procedures published in the 2021 NMPA Guideline on Post-Approval Changes.
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.
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

ChinaMarketing authorisations are valid for 5 years with mandatory renewal. Renewal application due ≥6 months before expiry; renewal review can take 90–180 working days.
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.
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

ChinaPharmacovigilance system aligned with ICH E2D/E2E since the 2021 Good Pharmacovigilance Practice (GVP) for Drugs entered force. PSURs follow ICH E2C(R2). MAH must establish a pharmacovigilance system, appoint a qualified person for pharmacovigilance (PV-QP), and report to the National Center for ADR Monitoring.
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.
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

ChinaAvailable
United StatesAvailable
European UnionAvailable

Compassionate Use

ChinaAvailable
United StatesAvailable
European UnionAvailable

Emergency Import

ChinaAvailable
United StatesAvailable
European UnionAvailable

Parallel Import

ChinaNot permitted
United StatesNot permitted
European UnionPermitted

Clinical trials

CTA approval

ChinaRequired
United StatesRequired
European UnionRequired

Ethics approval

ChinaYes
United StatesYes
European UnionYes

CTA timeline

China60–90 days
United States30–30 days
European Union60–106 days

GCP standard

ChinaChinese GCP (2020 revision, ICH E6(R2) aligned)
United StatesICH E6(R3) (adopted via FDA guidance January 2025); 21 CFR 312, 314, 50, 56
European UnionICH E6(R3) — Commission Regulation (EU) 2024/2748 transposing R3, applicable from 23 July 2025

Pricing & reimbursement

Price regulation

ChinaRegulated
United StatesFree pricing
European UnionRegulated

Reference pricing

ChinaNo
United StatesNo
European UnionYes

HTA required

ChinaYes
United StatesNo
European UnionYes

HTA body

ChinaNational Healthcare Security Administration (NHSA) — Centre for Medical Service Information
United StatesICER (Institute for Clinical and Economic Review) — independent, non-binding
European UnionEU HTA Coordination Group (EUnetHTA legacy); national HTA bodies (NICE, HAS, G-BA/IQWiG, AIFA, AEMPS, etc.)