§ 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	🇬🇧United Kingdom
Authority & dossier
Regulatory authority	DH DO	MHRA
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	FDA, EMA, Health Canada, Swissmedic +4
Lead pathway (timeline & fees) — Registration of Pharmaceutical Products containing NCE/NBE — '1+' Mechanism · International Recognition Procedure (IRP)
Pathway name	Registration of Pharmaceutical Products containing NCE/NBE — '1+' Mechanism	International Recognition Procedure (IRP)
Approval timeline	270–540 days	60–110 days
Application fee	HKD 12,330	GBP 35,305
Annual renewal	HKD 1,135	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	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 (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	1 designation	4 designations
Examples	'1+' Mechanism (Reliance with reduced CPP requirement)	Early Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1
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.	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	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; thereafter MA is granted for unlimited duration unless MHRA determines on PV grounds that one further 5-year renewal is justified.
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.	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	Permitted	Permitted
Clinical trials
CTA approval	Required	Required
Ethics approval	Yes	Yes
CTA timeline	30–90 days	30–60 days
GCP standard	ICH E6(R2/R3) GCP; Drug Office Good Clinical Practice Guidelines	ICH E6(R3) (MHRA adopted via Good Clinical Practice Guide; UK statutory instruments 2004/1031 as amended)
Pricing & reimbursement
Price regulation	Free pricing	Regulated
Reference pricing	No	No
HTA required	Yes	Yes
HTA body	Hospital Authority — Drug Advisory Committee (DAC) and Drug Utilisation Review Committee (DUC) for HA Drug Formulary listing	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

Hong KongDH DO
United KingdomMHRA

English submissions

Hong KongYes
United KingdomYes

CTD accepted

Hong KongYes
United KingdomYes

eCTD accepted

Hong KongNo
United KingdomYes

Reliance pathway

Hong KongAvailable
United KingdomAvailable

Reference agencies

Hong KongFDA (US), EMA, MHRA (UK), PMDA (Japan) +6
United KingdomFDA, EMA, Health Canada, Swissmedic +4

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

Pathway name

Hong KongRegistration of Pharmaceutical Products containing NCE/NBE — '1+' Mechanism
United KingdomInternational Recognition Procedure (IRP)

Approval timeline

Hong Kong270–540 days
United Kingdom60–110 days

Application fee

Hong KongHKD 12,330
United KingdomGBP 35,305

Annual renewal

Hong KongHKD 1,135
United KingdomGBP 0

Local representative

Hong KongRequired
United KingdomNot required

Local manufacturing

Hong KongNot required
United KingdomNot required

GMP inspection

Hong KongRequired
United KingdomNot required

MAH & local presence

Local entity required

Hong KongYes
United KingdomYes

Local responsible person

Hong KongYes
United KingdomYes

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.
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

Hong Kong1 designation
United Kingdom4 designations

Examples

Hong Kong'1+' Mechanism (Reliance with reduced CPP requirement)
United KingdomEarly Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1

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.
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

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.
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

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.
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

Hong KongAvailable
United KingdomAvailable

Compassionate Use

Hong KongAvailable
United KingdomAvailable

Emergency Import

Hong KongAvailable
United KingdomAvailable

Parallel Import

Hong KongPermitted
United KingdomPermitted

Clinical trials

CTA approval

Hong KongRequired
United KingdomRequired

Ethics approval

Hong KongYes
United KingdomYes

CTA timeline

Hong Kong30–90 days
United Kingdom30–60 days

GCP standard

Hong KongICH E6(R2/R3) GCP; Drug Office Good Clinical Practice Guidelines
United KingdomICH E6(R3) (MHRA adopted via Good Clinical Practice Guide; UK statutory instruments 2004/1031 as amended)

Pricing & reimbursement

Price regulation

Hong KongFree pricing
United KingdomRegulated

Reference pricing

Hong KongNo
United KingdomNo

HTA required

Hong KongYes
United KingdomYes

HTA body

Hong KongHospital Authority — Drug Advisory Committee (DAC) and Drug Utilisation Review Committee (DUC) for HA Drug Formulary listing
United KingdomNICE (England, Wales, NI), SMC (Scotland), AWMSG (Wales)