§ 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	🇮🇩Indonesia	🇪🇺European Union
Authority & dossier
Regulatory authority	BPOM	EMA
English submissions	Yes	Yes
CTD accepted	Yes	Yes
eCTD accepted	No	Yes
Reliance pathway	Available	Available
Reference agencies	FDA (US), EMA, MHRA (UK), Health Canada +5	—
Lead pathway (timeline & fees) — New Drug Registration (NCE / new biologic / new indication) · Centralised Procedure
Pathway name	New Drug Registration (NCE / new biologic / new indication)	Centralised Procedure
Approval timeline	300–540 days	210–277 days
Application fee	IDR 5,000,000	EUR 358,800
Annual renewal	IDR 0	EUR 122,500
Local representative	Required	Required
Local manufacturing	Not required	Not required
GMP inspection	Required	Required
MAH & local presence
Local entity required	Yes	Yes
Local responsible person	Yes	Yes
RP role	NIE holders must designate an Apoteker Penanggung Jawab (Responsible Pharmacist) for the licensed premises, and a contact person for pharmacovigilance reporting to BPOM's Pharmacovigilance Centre.	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	2 designations	6 designations
Examples	Public Health Emergency / Emergency Use Authorisation (EUA), Accelerated Registration for Critical Need / SRA-approved Products	Accelerated Assessment, Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +3
Post-approval lifecycle
Variations framework	Variations classified per BPOM Regulation No. 23/2025 and ASEAN Variation Guideline into Major Variation (MaV — BPOM approval), Minor Variation (MiV-PA prior approval, MiV-N notification) and Administrative Variation.	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	NIE is valid for 5 years and must be renewed before expiry, with up-to-date CMC, safety, labelling and Halal status information.	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	BPOM's Pharmacovigilance Centre (Pusat Farmakovigilans) coordinates national ADR reporting (Indonesia is a member of the WHO Programme for International Drug Monitoring, Uppsala). NIE holders must submit PSURs aligned to ICH E2C(R2), report serious ADRs within statutory timelines, and maintain a Risk Management Plan (RMP) for new active substances.	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
Compassionate Use	Available	Available
Emergency Import	Available	Available
Parallel Import	Not permitted	Permitted
Clinical trials
CTA approval	Required	Required
Ethics approval	Yes	Yes
CTA timeline	30–60 days	60–106 days
GCP standard	ICH E6(R2) GCP; BPOM Pedoman Cara Uji Klinik yang Baik (CUKB / Indonesian GCP)	ICH E6(R3) — Commission Regulation (EU) 2024/2748 transposing R3, applicable from 23 July 2025
Pricing & reimbursement
Price regulation	Regulated	Regulated
Reference pricing	Yes	Yes
HTA required	Yes	Yes
HTA body	InaHTAC — Indonesian Health Technology Assessment Committee	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

IndonesiaBPOM
European UnionEMA

English submissions

IndonesiaYes
European UnionYes

CTD accepted

IndonesiaYes
European UnionYes

eCTD accepted

IndonesiaNo
European UnionYes

Reliance pathway

IndonesiaAvailable
European UnionAvailable

Reference agencies

IndonesiaFDA (US), EMA, MHRA (UK), Health Canada +5
European Union—

Lead pathway (timeline & fees) — New Drug Registration (NCE / new biologic / new indication) · Centralised Procedure

Pathway name

IndonesiaNew Drug Registration (NCE / new biologic / new indication)
European UnionCentralised Procedure

Approval timeline

Indonesia300–540 days
European Union210–277 days

Application fee

IndonesiaIDR 5,000,000
European UnionEUR 358,800

Annual renewal

IndonesiaIDR 0
European UnionEUR 122,500

Local representative

IndonesiaRequired
European UnionRequired

Local manufacturing

IndonesiaNot required
European UnionNot required

GMP inspection

IndonesiaRequired
European UnionRequired

MAH & local presence

Local entity required

IndonesiaYes
European UnionYes

Local responsible person

IndonesiaYes
European UnionYes

RP role

IndonesiaNIE holders must designate an Apoteker Penanggung Jawab (Responsible Pharmacist) for the licensed premises, and a contact person for pharmacovigilance reporting to BPOM's Pharmacovigilance Centre.
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

Indonesia2 designations
European Union6 designations

Examples

IndonesiaPublic Health Emergency / Emergency Use Authorisation (EUA), Accelerated Registration for Critical Need / SRA-approved Products
European UnionAccelerated Assessment, Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +3

Post-approval lifecycle

Variations framework

IndonesiaVariations classified per BPOM Regulation No. 23/2025 and ASEAN Variation Guideline into Major Variation (MaV — BPOM approval), Minor Variation (MiV-PA prior approval, MiV-N notification) and Administrative Variation.
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

IndonesiaNIE is valid for 5 years and must be renewed before expiry, with up-to-date CMC, safety, labelling and Halal status information.
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

IndonesiaBPOM's Pharmacovigilance Centre (Pusat Farmakovigilans) coordinates national ADR reporting (Indonesia is a member of the WHO Programme for International Drug Monitoring, Uppsala). NIE holders must submit PSURs aligned to ICH E2C(R2), report serious ADRs within statutory timelines, and maintain a Risk Management Plan (RMP) for new active substances.
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

IndonesiaAvailable
European UnionAvailable

Compassionate Use

IndonesiaAvailable
European UnionAvailable

Emergency Import

IndonesiaAvailable
European UnionAvailable

Parallel Import

IndonesiaNot permitted
European UnionPermitted

Clinical trials

CTA approval

IndonesiaRequired
European UnionRequired

Ethics approval

IndonesiaYes
European UnionYes

CTA timeline

Indonesia30–60 days
European Union60–106 days

GCP standard

IndonesiaICH E6(R2) GCP; BPOM Pedoman Cara Uji Klinik yang Baik (CUKB / Indonesian GCP)
European UnionICH E6(R3) — Commission Regulation (EU) 2024/2748 transposing R3, applicable from 23 July 2025

Pricing & reimbursement

Price regulation

IndonesiaRegulated
European UnionRegulated

Reference pricing

IndonesiaYes
European UnionYes

HTA required

IndonesiaYes
European UnionYes

HTA body

IndonesiaInaHTAC — Indonesian Health Technology Assessment Committee
European UnionEU HTA Coordination Group (EUnetHTA legacy); national HTA bodies (NICE, HAS, G-BA/IQWiG, AIFA, AEMPS, etc.)