§ 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	🇭🇰Hong Kong	🇪🇺European Union
Authority & dossier
Regulatory authority	DH DO	EMA
English submissions	Yes	Yes
CTD accepted	Yes	Yes
eCTD accepted	No	Yes
Reliance pathway	Available	Available
Reference agencies	FDA (US), EMA, MHRA (UK), PMDA (Japan) +6	—
Lead pathway (timeline & fees) — Registration of Pharmaceutical Products containing NCE/NBE — '1+' Mechanism · Centralised Procedure
Pathway name	Registration of Pharmaceutical Products containing NCE/NBE — '1+' Mechanism	Centralised Procedure
Approval timeline	270–540 days	210–277 days
Application fee	HKD 12,330	EUR 358,800
Annual renewal	HKD 1,135	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	Certificate holders must designate a registered pharmacist (under the Pharmacists Registration Ordinance) as the responsible person for the licensed premises, and a contact for pharmacovigilance reporting to the Drug Office.	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	1 designation	6 designations
Examples	'1+' Mechanism (Reliance with reduced CPP requirement)	Accelerated Assessment, Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +3
Post-approval lifecycle
Variations framework	Variations classified per Drug Office guidelines into changes requiring approval (e.g. new indications, formulation, manufacturing site) and notifications (administrative). New indications under '1+' follow the new-drug pathway.	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	Certificate of Registration is valid for 5 years and must be renewed before expiry. Renewal requires up-to-date CMC, safety and labelling information, plus retention fee.	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	Certificate holders must report serious adverse drug reactions to the Drug Office's pharmacovigilance unit within statutory timelines, submit PSURs aligned to ICH E2C(R2), and maintain an RMP for new active substances. The Drug Office issues safety alerts via the Drug Office website.	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	Permitted	Permitted
Clinical trials
CTA approval	Required	Required
Ethics approval	Yes	Yes
CTA timeline	30–90 days	60–106 days
GCP standard	ICH E6(R2/R3) GCP; Drug Office Good Clinical Practice Guidelines	ICH E6(R3) — Commission Regulation (EU) 2024/2748 transposing R3, applicable from 23 July 2025
Pricing & reimbursement
Price regulation	Free pricing	Regulated
Reference pricing	No	Yes
HTA required	Yes	Yes
HTA body	Hospital Authority — Drug Advisory Committee (DAC) and Drug Utilisation Review Committee (DUC) for HA Drug Formulary listing	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

Hong KongDH DO
European UnionEMA

English submissions

Hong KongYes
European UnionYes

CTD accepted

Hong KongYes
European UnionYes

eCTD accepted

Hong KongNo
European UnionYes

Reliance pathway

Hong KongAvailable
European UnionAvailable

Reference agencies

Hong KongFDA (US), EMA, MHRA (UK), PMDA (Japan) +6
European Union—

Lead pathway (timeline & fees) — Registration of Pharmaceutical Products containing NCE/NBE — '1+' Mechanism · Centralised Procedure

Pathway name

Hong KongRegistration of Pharmaceutical Products containing NCE/NBE — '1+' Mechanism
European UnionCentralised Procedure

Approval timeline

Hong Kong270–540 days
European Union210–277 days

Application fee

Hong KongHKD 12,330
European UnionEUR 358,800

Annual renewal

Hong KongHKD 1,135
European UnionEUR 122,500

Local representative

Hong KongRequired
European UnionRequired

Local manufacturing

Hong KongNot required
European UnionNot required

GMP inspection

Hong KongRequired
European UnionRequired

MAH & local presence

Local entity required

Hong KongYes
European UnionYes

Local responsible person

Hong KongYes
European UnionYes

RP role

Hong KongCertificate holders must designate a registered pharmacist (under the Pharmacists Registration Ordinance) as the responsible person for the licensed premises, and a contact for pharmacovigilance reporting to the Drug Office.
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

Hong Kong1 designation
European Union6 designations

Examples

Hong Kong'1+' Mechanism (Reliance with reduced CPP requirement)
European UnionAccelerated Assessment, Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +3

Post-approval lifecycle

Variations framework

Hong KongVariations classified per Drug Office guidelines into changes requiring approval (e.g. new indications, formulation, manufacturing site) and notifications (administrative). New indications under '1+' follow the new-drug pathway.
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

Hong KongCertificate of Registration is valid for 5 years and must be renewed before expiry. Renewal requires up-to-date CMC, safety and labelling information, plus retention fee.
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

Hong KongCertificate holders must report serious adverse drug reactions to the Drug Office's pharmacovigilance unit within statutory timelines, submit PSURs aligned to ICH E2C(R2), and maintain an RMP for new active substances. The Drug Office issues safety alerts via the Drug Office website.
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

Hong KongAvailable
European UnionAvailable

Compassionate Use

Hong KongAvailable
European UnionAvailable

Emergency Import

Hong KongAvailable
European UnionAvailable

Parallel Import

Hong KongPermitted
European UnionPermitted

Clinical trials

CTA approval

Hong KongRequired
European UnionRequired

Ethics approval

Hong KongYes
European UnionYes

CTA timeline

Hong Kong30–90 days
European Union60–106 days

GCP standard

Hong KongICH E6(R2/R3) GCP; Drug Office Good Clinical Practice Guidelines
European UnionICH E6(R3) — Commission Regulation (EU) 2024/2748 transposing R3, applicable from 23 July 2025

Pricing & reimbursement

Price regulation

Hong KongFree pricing
European UnionRegulated

Reference pricing

Hong KongNo
European UnionYes

HTA required

Hong KongYes
European UnionYes

HTA body

Hong KongHospital Authority — Drug Advisory Committee (DAC) and Drug Utilisation Review Committee (DUC) for HA Drug Formulary listing
European UnionEU HTA Coordination Group (EUnetHTA legacy); national HTA bodies (NICE, HAS, G-BA/IQWiG, AIFA, AEMPS, etc.)