§ 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, Standard Review · Centralised Procedure
Pathway name
- South KoreaNew Drug Application, Standard Review
- European UnionCentralised Procedure
Approval timeline
- South Korea365-480 days
- European Union210-277 days
Headline fee and pathway
- South KoreaFees not covered
- European UnionEUR 865,200, Centralised Procedureconditional on other
Recurring charges
- South KoreaFees not covered
- European UnionEUR 232,400 a year, per marketing authorisation, other applications
Local representative
- South KoreaRequired
- European UnionRequired
Local manufacturing
- South KoreaNot required
- European UnionNot required
GMP inspection
- South KoreaRequired
- European UnionRequired
MAH & local presence
Local entity required
- South KoreaYes
- European UnionYes
Local responsible person
- South KoreaYes
- European UnionYes
RP role
- South KoreaQualified Person for Safety Management (안전관리책임자): Korea-resident pharmacist responsible for pharmacovigilance and post-marketing safety obligations. A separate Quality Manager is required for manufacturing/import licences.
- 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
- South Korea5 designations
- European Union6 designations
Examples
- South KoreaGlobal Innovative Products on Fast Track (GIFT), Priority Review, Conditional Approval +2
- European UnionAccelerated Assessment, Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +3
Post-approval lifecycle
Variations framework
- South KoreaMFDS classifies post-approval changes as Major, Moderate, and Minor variations, broadly aligned with EU classification. Annual report categories also exist for the smallest 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
- South KoreaMarketing authorisations require renewal every 5 years. Renewal application must be submitted 6 months before expiry. Re-examination period (재심사기간) of 4 to 6 years applies to new drugs requiring active safety monitoring with full re-evaluation.
- 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
- South KoreaKorea Adverse Event Reporting System (KAERS) administered by the Korea Institute of Drug Safety and Risk Management (KIDS). PSURs aligned with ICH E2C(R2). MAH must appoint a Qualified Person for Safety Management and maintain a pharmacovigilance 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
- South KoreaAvailable
- European UnionAvailable
Compassionate Use
- South KoreaAvailable
- European UnionAvailable
Emergency Import
- South KoreaAvailable
- European UnionAvailable
Parallel Import
- South KoreaNot permitted
- European UnionPermitted
Clinical trials
CTA approval
- South KoreaRequired
- European UnionRequired
Ethics approval
- South KoreaYes
- European UnionYes
CTA timeline
- South Korea30-60 days
- European Union60-106 days
GCP standard
- South KoreaKorean GCP (KGCP, ICH E6(R3) aligned)
- European UnionICH E6(R3), Commission Regulation (EU) 2024/2748 transposing R3, applicable from 23 July 2025
Pricing & reimbursement
Price regulation
- South KoreaRegulated
- European UnionRegulated
Reference pricing
- South KoreaYes
- European UnionYes
HTA required
- South KoreaYes
- European UnionYes
HTA body
- South KoreaHealth Insurance Review and Assessment Service (HIRA), Pharmaceutical Benefits Coverage Assessment Committee
- European UnionEU HTA Coordination Group (EUnetHTA legacy); national HTA bodies (NICE, HAS, G-BA/IQWiG, AIFA, AEMPS, etc.)