§ 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	🇨🇳China	🇬🇧United Kingdom
Authority & dossier
Regulatory authority	NMPA	MHRA
English submissions	No	Yes
CTD accepted	Yes	Yes
eCTD accepted	Yes	Yes
Reliance pathway	None	Available
Reference agencies	FDA, EMA, MHRA, PMDA +2	FDA, EMA, Health Canada, Swissmedic +4
Lead pathway (timeline & fees) — New Drug Application (Class 1) — Innovative Drug · International Recognition Procedure (IRP)
Pathway name	New Drug Application (Class 1) — Innovative Drug	International Recognition Procedure (IRP)
Approval timeline	200–365 days	60–110 days
Application fee	CNY 622,500	GBP 35,305
Annual renewal	CNY 23,800	GBP 0
Local representative	Required	Not required
Local manufacturing	Not required	Not required
GMP inspection	Required	Not required
MAH & local presence
Local entity required	No	Yes
Local responsible person	Yes	Yes
RP role	Authorised Agent (境内代理人): Chinese-incorporated entity responsible for NMPA communications, pharmacovigilance reporting, recall coordination, and pharmacovigilance system master file maintenance. The MAH must also appoint a qualified person for pharmacovigilance and a qualified person for quality.	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	5 designations	4 designations
Examples	Breakthrough Therapy Designation (突破性治疗药物), Priority Review (优先审评), Conditional Approval (附条件批准) +2	Early Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1
Post-approval lifecycle
Variations framework	Post-approval changes classified as Major (重大), Moderate (中等), and Minor (微小) variations, broadly aligned with ICH Q12 principles but with China-specific procedures published in the 2021 NMPA Guideline on Post-Approval Changes.	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	Marketing authorisations are valid for 5 years with mandatory renewal. Renewal application due ≥6 months before expiry; renewal review can take 90–180 working days.	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	Pharmacovigilance system aligned with ICH E2D/E2E since the 2021 Good Pharmacovigilance Practice (GVP) for Drugs entered force. PSURs follow ICH E2C(R2). MAH must establish a pharmacovigilance system, appoint a qualified person for pharmacovigilance (PV-QP), and report to the National Center for ADR Monitoring.	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	60–90 days	30–60 days
GCP standard	Chinese GCP (2020 revision, ICH E6(R2) aligned)	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	No	No
HTA required	Yes	Yes
HTA body	National Healthcare Security Administration (NHSA) — Centre for Medical Service Information	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

ChinaNMPA
United KingdomMHRA

English submissions

ChinaNo
United KingdomYes

CTD accepted

ChinaYes
United KingdomYes

eCTD accepted

ChinaYes
United KingdomYes

Reliance pathway

ChinaNone
United KingdomAvailable

Reference agencies

ChinaFDA, EMA, MHRA, PMDA +2
United KingdomFDA, EMA, Health Canada, Swissmedic +4

Lead pathway (timeline & fees) — New Drug Application (Class 1) — Innovative Drug · International Recognition Procedure (IRP)

Pathway name

ChinaNew Drug Application (Class 1) — Innovative Drug
United KingdomInternational Recognition Procedure (IRP)

Approval timeline

China200–365 days
United Kingdom60–110 days

Application fee

ChinaCNY 622,500
United KingdomGBP 35,305

Annual renewal

ChinaCNY 23,800
United KingdomGBP 0

Local representative

ChinaRequired
United KingdomNot required

Local manufacturing

ChinaNot required
United KingdomNot required

GMP inspection

ChinaRequired
United KingdomNot required

MAH & local presence

Local entity required

ChinaNo
United KingdomYes

Local responsible person

ChinaYes
United KingdomYes

RP role

ChinaAuthorised Agent (境内代理人): Chinese-incorporated entity responsible for NMPA communications, pharmacovigilance reporting, recall coordination, and pharmacovigilance system master file maintenance. The MAH must also appoint a qualified person for pharmacovigilance and a qualified person for quality.
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

China5 designations
United Kingdom4 designations

Examples

ChinaBreakthrough Therapy Designation (突破性治疗药物), Priority Review (优先审评), Conditional Approval (附条件批准) +2
United KingdomEarly Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1

Post-approval lifecycle

Variations framework

ChinaPost-approval changes classified as Major (重大), Moderate (中等), and Minor (微小) variations, broadly aligned with ICH Q12 principles but with China-specific procedures published in the 2021 NMPA Guideline on Post-Approval Changes.
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

ChinaMarketing authorisations are valid for 5 years with mandatory renewal. Renewal application due ≥6 months before expiry; renewal review can take 90–180 working days.
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

ChinaPharmacovigilance system aligned with ICH E2D/E2E since the 2021 Good Pharmacovigilance Practice (GVP) for Drugs entered force. PSURs follow ICH E2C(R2). MAH must establish a pharmacovigilance system, appoint a qualified person for pharmacovigilance (PV-QP), and report to the National Center for ADR Monitoring.
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

ChinaAvailable
United KingdomAvailable

Compassionate Use

ChinaAvailable
United KingdomAvailable

Emergency Import

ChinaAvailable
United KingdomAvailable

Parallel Import

ChinaNot permitted
United KingdomPermitted

Clinical trials

CTA approval

ChinaRequired
United KingdomRequired

Ethics approval

ChinaYes
United KingdomYes

CTA timeline

China60–90 days
United Kingdom30–60 days

GCP standard

ChinaChinese GCP (2020 revision, ICH E6(R2) aligned)
United KingdomICH E6(R3) (MHRA adopted via Good Clinical Practice Guide; UK statutory instruments 2004/1031 as amended)

Pricing & reimbursement

Price regulation

ChinaRegulated
United KingdomRegulated

Reference pricing

ChinaNo
United KingdomNo

HTA required

ChinaYes
United KingdomYes

HTA body

ChinaNational Healthcare Security Administration (NHSA) — Centre for Medical Service Information
United KingdomNICE (England, Wales, NI), SMC (Scotland), AWMSG (Wales)