§ 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	🇹🇭Thailand	🇬🇧United Kingdom
Authority & dossier
Regulatory authority	Thai FDA	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 Review · International Recognition Procedure (IRP)
Pathway name	New Drug Registration — Standard Review	International Recognition Procedure (IRP)
Approval timeline	365–730 days	60–110 days
Application fee	THB 100,000	GBP 35,305
Annual renewal	THB 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	Registration holders must designate a qualified pharmacist (registered with the Pharmacy Council of Thailand) as the responsible person for the licensed premises, and a contact for pharmacovigilance reporting.	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 Approval, Safety Monitoring Programme (SMP) Conditional Registration	Early Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1
Post-approval lifecycle
Variations framework	Variations classified per Thai FDA guidelines into major (require approval — e.g., new indication, formulation change, new manufacturing site) and minor (notification). New indications follow the new-drug pathway with SMP.	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	Drug registration is valid indefinitely for most products once unconditional, subject to ongoing pharmacovigilance and GMP compliance; controlled substances and biologicals follow specific renewal cycles.	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	Thai FDA's Health Product Vigilance Centre (HPVC) coordinates national ADR reporting (Thailand is a member of the WHO Programme for International Drug Monitoring, Uppsala). Marketing authorisation 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. The SMP provides additional intensive monitoring for the first 2 years.	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; Thai FDA 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	Regulated	Regulated
Reference pricing	Yes	No
HTA required	Yes	Yes
HTA body	Health Intervention and Technology Assessment Program (HITAP) — supporting NLEM Subcommittee	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

ThailandThai FDA
United KingdomMHRA

English submissions

ThailandYes
United KingdomYes

CTD accepted

ThailandYes
United KingdomYes

eCTD accepted

ThailandNo
United KingdomYes

Reliance pathway

ThailandAvailable
United KingdomAvailable

Reference agencies

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

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

Pathway name

ThailandNew Drug Registration — Standard Review
United KingdomInternational Recognition Procedure (IRP)

Approval timeline

Thailand365–730 days
United Kingdom60–110 days

Application fee

ThailandTHB 100,000
United KingdomGBP 35,305

Annual renewal

ThailandTHB 0
United KingdomGBP 0

Local representative

ThailandRequired
United KingdomNot required

Local manufacturing

ThailandNot required
United KingdomNot required

GMP inspection

ThailandRequired
United KingdomNot required

MAH & local presence

Local entity required

ThailandYes
United KingdomYes

Local responsible person

ThailandYes
United KingdomYes

RP role

ThailandRegistration holders must designate a qualified pharmacist (registered with the Pharmacy Council of Thailand) as the responsible person for the licensed premises, and a contact for pharmacovigilance reporting.
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

Thailand2 designations
United Kingdom4 designations

Examples

ThailandPublic Health Emergency / Conditional Approval, Safety Monitoring Programme (SMP) Conditional Registration
United KingdomEarly Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1

Post-approval lifecycle

Variations framework

ThailandVariations classified per Thai FDA guidelines into major (require approval — e.g., new indication, formulation change, new manufacturing site) and minor (notification). New indications follow the new-drug pathway with SMP.
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

ThailandDrug registration is valid indefinitely for most products once unconditional, subject to ongoing pharmacovigilance and GMP compliance; controlled substances and biologicals follow specific renewal cycles.
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

ThailandThai FDA's Health Product Vigilance Centre (HPVC) coordinates national ADR reporting (Thailand is a member of the WHO Programme for International Drug Monitoring, Uppsala). Marketing authorisation 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. The SMP provides additional intensive monitoring for the first 2 years.
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

ThailandAvailable
United KingdomAvailable

Compassionate Use

ThailandAvailable
United KingdomAvailable

Emergency Import

ThailandAvailable
United KingdomAvailable

Parallel Import

ThailandNot permitted
United KingdomPermitted

Clinical trials

CTA approval

ThailandRequired
United KingdomRequired

Ethics approval

ThailandYes
United KingdomYes

CTA timeline

Thailand60–120 days
United Kingdom30–60 days

GCP standard

ThailandICH E6(R2) GCP; Thai FDA 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

ThailandRegulated
United KingdomRegulated

Reference pricing

ThailandYes
United KingdomNo

HTA required

ThailandYes
United KingdomYes

HTA body

ThailandHealth Intervention and Technology Assessment Program (HITAP) — supporting NLEM Subcommittee
United KingdomNICE (England, Wales, NI), SMC (Scotland), AWMSG (Wales)