§ 02 · Comparison
Compare regulatory pathways side-by-side
Benchmark MAHMAH, GMPGMP, HTAHTA and pathway requirements across up to three markets.
Lead pathway (timeline & fees), New Drug Application (Class 1), Innovative Drug · Centralised Procedure
Pathway name
- ChinaNew Drug Application (Class 1), Innovative Drug
- European UnionCentralised Procedure
Approval timeline
- China200-365 days
- European Union210-277 days
Headline fee and pathway
- ChinaCNY 432,000, New Drug Application (Class 1), Innovative Drugconditional on other, place of manufacture
- European UnionEUR 865,200, Centralised Procedureconditional on other
Recurring charges
- ChinaCNY 227,200 every 5 years, per registration, overseas produced. Provinces set the domestic rate.
- European UnionEUR 232,400 a year, per marketing authorisation, other applications
Local representative
- ChinaRequired
- European UnionRequired
Local manufacturing
- ChinaNot required
- European UnionNot required
GMP inspection
- ChinaRequired
- European UnionRequired
MAH & local presence
Local entity required
- ChinaNo
- European UnionYes
Local responsible person
- ChinaYes
- 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.
- 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
- 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
- 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.
- 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 to 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 to 180 working days.
- 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.
- 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
- European UnionAvailable
Compassionate Use
- ChinaAvailable
- European UnionAvailable
Emergency Import
- ChinaAvailable
- European UnionAvailable
Parallel Import
- ChinaNot permitted
- European UnionPermitted
Clinical trials
CTA approval
- ChinaRequired
- European UnionRequired
Ethics approval
- ChinaYes
- European UnionYes
CTA timeline
- China60-90 days
- European Union60-106 days
GCP standard
- ChinaChinese GCP (2020 revision, ICH E6(R2) aligned)
- European UnionICH E6(R3), Commission Regulation (EU) 2024/2748 transposing R3, applicable from 23 July 2025
Pricing & reimbursement
Price regulation
- ChinaRegulated
- European UnionRegulated
Reference pricing
- ChinaNo
- European UnionYes
HTA required
- ChinaYes
- European UnionYes
HTA body
- ChinaNational Healthcare Security Administration (NHSA), Centre for Medical Service Information
- European UnionEU HTA Coordination Group (EUnetHTA legacy); national HTA bodies (NICE, HAS, G-BA/IQWiG, AIFA, AEMPS, etc.)