§ 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	🇻🇳Vietnam	🇬🇧United Kingdom
Authority & dossier
Regulatory authority	DAV	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 +4	FDA, EMA, Health Canada, Swissmedic +4
Lead pathway (timeline & fees) — New Drug Registration — Standard Visa · International Recognition Procedure (IRP)
Pathway name	New Drug Registration — Standard Visa	International Recognition Procedure (IRP)
Approval timeline	270–540 days	60–110 days
Application fee	VND 11,000,000	GBP 35,305
Annual renewal	VND 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	Visa holders must designate a registered pharmacist (Chief Pharmacist) responsible for quality and pharmacovigilance, and a contact for the National DI&ADR 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 / Conditional Visa, Auto-extension of Marketing Authorisation	Early Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1
Post-approval lifecycle
Variations framework	Variations classified per Circular 08/2022/TT-BYT and Circular 12/2025/TT-BYT into Major Variation (DAV approval), Minor Variation (notification or prior approval) and Administrative Variation, broadly aligned with ASEAN Variation Guideline.	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	Visa is valid for 5 years (or 3 years for products with conditional approval / new active substances), renewable; Circular 08/2022 introduced auto-extension during DAV review of renewals.	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	Vietnam's National Centre of Drug Information and Adverse Drug Reactions Monitoring (DI&ADR Centre) coordinates national ADR reporting (Vietnam is a member of the WHO Programme for International Drug Monitoring, Uppsala). Visa 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	60–120 days	30–60 days
GCP standard	ICH E6(R2) GCP; MoH Vietnamese GCP guidelines	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	No	Yes
HTA body	MoH Reimbursement Drug List Council (HTA capability developing — Health Strategy and Policy Institute, HSPI)	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

VietnamDAV
United KingdomMHRA

English submissions

VietnamYes
United KingdomYes

CTD accepted

VietnamYes
United KingdomYes

eCTD accepted

VietnamNo
United KingdomYes

Reliance pathway

VietnamAvailable
United KingdomAvailable

Reference agencies

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

Lead pathway (timeline & fees) — New Drug Registration — Standard Visa · International Recognition Procedure (IRP)

Pathway name

VietnamNew Drug Registration — Standard Visa
United KingdomInternational Recognition Procedure (IRP)

Approval timeline

Vietnam270–540 days
United Kingdom60–110 days

Application fee

VietnamVND 11,000,000
United KingdomGBP 35,305

Annual renewal

VietnamVND 0
United KingdomGBP 0

Local representative

VietnamRequired
United KingdomNot required

Local manufacturing

VietnamNot required
United KingdomNot required

GMP inspection

VietnamRequired
United KingdomNot required

MAH & local presence

Local entity required

VietnamYes
United KingdomYes

Local responsible person

VietnamYes
United KingdomYes

RP role

VietnamVisa holders must designate a registered pharmacist (Chief Pharmacist) responsible for quality and pharmacovigilance, and a contact for the National DI&ADR 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

Vietnam2 designations
United Kingdom4 designations

Examples

VietnamPublic Health Emergency / Conditional Visa, Auto-extension of Marketing Authorisation
United KingdomEarly Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1

Post-approval lifecycle

Variations framework

VietnamVariations classified per Circular 08/2022/TT-BYT and Circular 12/2025/TT-BYT into Major Variation (DAV approval), Minor Variation (notification or prior approval) and Administrative Variation, broadly aligned with ASEAN Variation Guideline.
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

VietnamVisa is valid for 5 years (or 3 years for products with conditional approval / new active substances), renewable; Circular 08/2022 introduced auto-extension during DAV review of renewals.
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

VietnamVietnam's National Centre of Drug Information and Adverse Drug Reactions Monitoring (DI&ADR Centre) coordinates national ADR reporting (Vietnam is a member of the WHO Programme for International Drug Monitoring, Uppsala). Visa 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

VietnamAvailable
United KingdomAvailable

Compassionate Use

VietnamAvailable
United KingdomAvailable

Emergency Import

VietnamAvailable
United KingdomAvailable

Parallel Import

VietnamNot permitted
United KingdomPermitted

Clinical trials

CTA approval

VietnamRequired
United KingdomRequired

Ethics approval

VietnamYes
United KingdomYes

CTA timeline

Vietnam60–120 days
United Kingdom30–60 days

GCP standard

VietnamICH E6(R2) GCP; MoH Vietnamese GCP guidelines
United KingdomICH E6(R3) (MHRA adopted via Good Clinical Practice Guide; UK statutory instruments 2004/1031 as amended)

Pricing & reimbursement

Price regulation

VietnamRegulated
United KingdomRegulated

Reference pricing

VietnamYes
United KingdomNo

HTA required

VietnamNo
United KingdomYes

HTA body

VietnamMoH Reimbursement Drug List Council (HTA capability developing — Health Strategy and Policy Institute, HSPI)
United KingdomNICE (England, Wales, NI), SMC (Scotland), AWMSG (Wales)