§ 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	🇹🇼Taiwan	🇬🇧United Kingdom
Authority & dossier
Regulatory authority	TFDA	MHRA
English submissions	Yes	Yes
CTD accepted	Yes	Yes
eCTD accepted	Yes	Yes
Reliance pathway	Available	Available
Reference agencies	FDA, EMA, PMDA, MHRA +3	FDA, EMA, Health Canada, Swissmedic +4
Lead pathway (timeline & fees) — New Drug Application (NDA / BLA) — Standard · International Recognition Procedure (IRP)
Pathway name	New Drug Application (NDA / BLA) — Standard	International Recognition Procedure (IRP)
Approval timeline	360–540 days	60–110 days
Application fee	TWD 720,000	GBP 35,305
Annual renewal	TWD 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	Licence holders must designate a qualified pharmacist or medical professional as the responsible person for pharmacovigilance, ADR reporting to TFDA's National ADR Reporting System, and quality matters.	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	3 designations	4 designations
Examples	Priority Review, Orphan Drug Designation, TFDA–PMDA Parallel Review	Early Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1
Post-approval lifecycle
Variations framework	Variations classified as either notification (minor) or approval (major) changes per the Regulations for Registration of Medicinal Products. Major changes (new indications, manufacturing site changes, formulation changes) require TFDA approval; minor administrative changes are notified.	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 licences are valid for 5 years and must be renewed before expiry. Renewal requires updated CMC, safety and labelling information; failure to renew results in licence lapse.	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	MA holders must report serious ADRs to TFDA's National ADR Reporting System within 15 days, submit PSURs aligned to ICH E2C(R2), and maintain RMPs for new active substances and biologics. Taiwan's National Drug ADR Reporting System is operated by the National Drug Information Center.	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	30–60 days	30–60 days
GCP standard	ICH E6(R2/R3) GCP; TFDA Good Clinical Practice (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	Yes	Yes
HTA body	Center for Drug Evaluation (CDE) — HTA Division	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

TaiwanTFDA
United KingdomMHRA

English submissions

TaiwanYes
United KingdomYes

CTD accepted

TaiwanYes
United KingdomYes

eCTD accepted

TaiwanYes
United KingdomYes

Reliance pathway

TaiwanAvailable
United KingdomAvailable

Reference agencies

TaiwanFDA, EMA, PMDA, MHRA +3
United KingdomFDA, EMA, Health Canada, Swissmedic +4

Lead pathway (timeline & fees) — New Drug Application (NDA / BLA) — Standard · International Recognition Procedure (IRP)

Pathway name

TaiwanNew Drug Application (NDA / BLA) — Standard
United KingdomInternational Recognition Procedure (IRP)

Approval timeline

Taiwan360–540 days
United Kingdom60–110 days

Application fee

TaiwanTWD 720,000
United KingdomGBP 35,305

Annual renewal

TaiwanTWD 0
United KingdomGBP 0

Local representative

TaiwanRequired
United KingdomNot required

Local manufacturing

TaiwanNot required
United KingdomNot required

GMP inspection

TaiwanRequired
United KingdomNot required

MAH & local presence

Local entity required

TaiwanYes
United KingdomYes

Local responsible person

TaiwanYes
United KingdomYes

RP role

TaiwanLicence holders must designate a qualified pharmacist or medical professional as the responsible person for pharmacovigilance, ADR reporting to TFDA's National ADR Reporting System, and quality matters.
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

Taiwan3 designations
United Kingdom4 designations

Examples

TaiwanPriority Review, Orphan Drug Designation, TFDA–PMDA Parallel Review
United KingdomEarly Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1

Post-approval lifecycle

Variations framework

TaiwanVariations classified as either notification (minor) or approval (major) changes per the Regulations for Registration of Medicinal Products. Major changes (new indications, manufacturing site changes, formulation changes) require TFDA approval; minor administrative changes are notified.
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

TaiwanDrug licences are valid for 5 years and must be renewed before expiry. Renewal requires updated CMC, safety and labelling information; failure to renew results in licence lapse.
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

TaiwanMA holders must report serious ADRs to TFDA's National ADR Reporting System within 15 days, submit PSURs aligned to ICH E2C(R2), and maintain RMPs for new active substances and biologics. Taiwan's National Drug ADR Reporting System is operated by the National Drug Information Center.
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

TaiwanAvailable
United KingdomAvailable

Compassionate Use

TaiwanAvailable
United KingdomAvailable

Emergency Import

TaiwanAvailable
United KingdomAvailable

Parallel Import

TaiwanNot permitted
United KingdomPermitted

Clinical trials

CTA approval

TaiwanRequired
United KingdomRequired

Ethics approval

TaiwanYes
United KingdomYes

CTA timeline

Taiwan30–60 days
United Kingdom30–60 days

GCP standard

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

Pricing & reimbursement

Price regulation

TaiwanRegulated
United KingdomRegulated

Reference pricing

TaiwanYes
United KingdomNo

HTA required

TaiwanYes
United KingdomYes

HTA body

TaiwanCenter for Drug Evaluation (CDE) — HTA Division
United KingdomNICE (England, Wales, NI), SMC (Scotland), AWMSG (Wales)