§ 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	🇬🇧United Kingdom
Authority & dossier
Regulatory authority	BPOM	MHRA
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	FDA, EMA, Health Canada, Swissmedic +4
Lead pathway (timeline & fees) — New Drug Registration (NCE / new biologic / new indication) · International Recognition Procedure (IRP)
Pathway name	New Drug Registration (NCE / new biologic / new indication)	International Recognition Procedure (IRP)
Approval timeline	300–540 days	60–110 days
Application fee	IDR 5,000,000	GBP 35,305
Annual renewal	IDR 0	GBP 0
Local representative	Required	Not required
Local manufacturing	Not required	Not required
GMP inspection	Required	Not 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 (Pharmacovigilance) — QPPV — must reside in the UK or EEA. UK Responsible Person (Import) for batch certification of products imported into GB. Local pharmacovigilance contact in the UK required for risk minimisation activities.
Accelerated pathways
Designations available	2 designations	4 designations
Examples	Public Health Emergency / Emergency Use Authorisation (EUA), Accelerated Registration for Critical Need / SRA-approved Products	Early Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1
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.	Variations classified per UK Variations Regulations (mirroring EU Reg 1234/2008): Type IA, IAIN, IB, II, and Extensions. MHRA Worksharing available for grouped 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; thereafter MA is granted for unlimited duration unless MHRA determines on PV grounds that one further 5-year renewal is justified.
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.	MHRA operates the Yellow Card Scheme for ADR reporting. PSURs follow the EU Reference Date list pre-Brexit, with MHRA UK-specific PSUR list since 2021. RMPs required for new MAs and significant variations. Black triangle (▼) for additional monitoring.
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	30–60 days
GCP standard	ICH E6(R2) GCP; BPOM Pedoman Cara Uji Klinik yang Baik (CUKB / Indonesian GCP)	ICH E6(R3) (MHRA adopted via Good Clinical Practice Guide; UK statutory instruments 2004/1031 as amended)
Pricing & reimbursement
Price regulation	Regulated	Regulated
Reference pricing	Yes	No
HTA required	Yes	Yes
HTA body	InaHTAC — Indonesian Health Technology Assessment Committee	NICE (England, Wales, NI), SMC (Scotland), AWMSG (Wales)

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

Authority & dossier

Regulatory authority

IndonesiaBPOM
United KingdomMHRA

English submissions

IndonesiaYes
United KingdomYes

CTD accepted

IndonesiaYes
United KingdomYes

eCTD accepted

IndonesiaNo
United KingdomYes

Reliance pathway

IndonesiaAvailable
United KingdomAvailable

Reference agencies

IndonesiaFDA (US), EMA, MHRA (UK), Health Canada +5
United KingdomFDA, EMA, Health Canada, Swissmedic +4

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

Pathway name

IndonesiaNew Drug Registration (NCE / new biologic / new indication)
United KingdomInternational Recognition Procedure (IRP)

Approval timeline

Indonesia300–540 days
United Kingdom60–110 days

Application fee

IndonesiaIDR 5,000,000
United KingdomGBP 35,305

Annual renewal

IndonesiaIDR 0
United KingdomGBP 0

Local representative

IndonesiaRequired
United KingdomNot required

Local manufacturing

IndonesiaNot required
United KingdomNot required

GMP inspection

IndonesiaRequired
United KingdomNot required

MAH & local presence

Local entity required

IndonesiaYes
United KingdomYes

Local responsible person

IndonesiaYes
United KingdomYes

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.
United KingdomQualified Person (Pharmacovigilance) — QPPV — must reside in the UK or EEA. UK Responsible Person (Import) for batch certification of products imported into GB. Local pharmacovigilance contact in the UK required for risk minimisation activities.

Accelerated pathways

Designations available

Indonesia2 designations
United Kingdom4 designations

Examples

IndonesiaPublic Health Emergency / Emergency Use Authorisation (EUA), Accelerated Registration for Critical Need / SRA-approved Products
United KingdomEarly Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1

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.
United KingdomVariations classified per UK Variations Regulations (mirroring EU Reg 1234/2008): Type IA, IAIN, IB, II, and Extensions. MHRA Worksharing available for grouped 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.
United KingdomInitial 5-year renewal; thereafter MA is granted for unlimited duration unless MHRA determines on PV grounds that one further 5-year renewal is justified.

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.
United KingdomMHRA operates the Yellow Card Scheme for ADR reporting. PSURs follow the EU Reference Date list pre-Brexit, with MHRA UK-specific PSUR list since 2021. RMPs required for new MAs and significant variations. Black triangle (▼) for additional monitoring.

Unlicensed access

Named Patient Supply

IndonesiaAvailable
United KingdomAvailable

Compassionate Use

IndonesiaAvailable
United KingdomAvailable

Emergency Import

IndonesiaAvailable
United KingdomAvailable

Parallel Import

IndonesiaNot permitted
United KingdomPermitted

Clinical trials

CTA approval

IndonesiaRequired
United KingdomRequired

Ethics approval

IndonesiaYes
United KingdomYes

CTA timeline

Indonesia30–60 days
United Kingdom30–60 days

GCP standard

IndonesiaICH E6(R2) GCP; BPOM Pedoman Cara Uji Klinik yang Baik (CUKB / Indonesian GCP)
United KingdomICH E6(R3) (MHRA adopted via Good Clinical Practice Guide; UK statutory instruments 2004/1031 as amended)

Pricing & reimbursement

Price regulation

IndonesiaRegulated
United KingdomRegulated

Reference pricing

IndonesiaYes
United KingdomNo

HTA required

IndonesiaYes
United KingdomYes

HTA body

IndonesiaInaHTAC — Indonesian Health Technology Assessment Committee
United KingdomNICE (England, Wales, NI), SMC (Scotland), AWMSG (Wales)