§ 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 States
Authority & dossier
Regulatory authority	TFDA	FDA
English submissions	Yes	Yes
CTD accepted	Yes	Yes
eCTD accepted	Yes	Yes
Reliance pathway	Available	None
Reference agencies	FDA, EMA, PMDA, MHRA +3	—
Lead pathway (timeline & fees) — New Drug Application (NDA / BLA) — Standard · New Drug Application — 505(b)(1)
Pathway name	New Drug Application (NDA / BLA) — Standard	New Drug Application — 505(b)(1)
Approval timeline	360–540 days	304–365 days
Application fee	TWD 720,000	USD 4,310,002
Annual renewal	TWD 0	USD 416,734
Local representative	Required	Not required
Local manufacturing	Not required	Not required
GMP inspection	Required	Required
MAH & local presence
Local entity required	Yes	No
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.	US Agent: a person residing or maintaining a place of business in the US, designated to act on behalf of the foreign establishment for FDA communications, including notification of inspections.
Accelerated pathways
Designations available	3 designations	6 designations
Examples	Priority Review, Orphan Drug Designation, TFDA–PMDA Parallel Review	Priority Review, Breakthrough Therapy Designation, Accelerated Approval — Subpart H/E +3
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.	FDA classifies post-approval changes as: Annual Reportable, Changes Being Effected (CBE-0 immediate, CBE-30 with 30-day pre-implementation notice), and Prior Approval Supplements (PAS) — the most significant changes requiring FDA approval before implementation. Major manufacturing or labelling changes typically require a PAS.
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.	FDA does not require periodic renewal of NDAs or BLAs — approvals remain in effect indefinitely subject to compliance, payment of annual program fees, and post-marketing requirements. Annual reports are required.
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.	Mandatory expedited reporting of serious unexpected ADRs within 15 calendar days; periodic safety reports (PADERs/PAERs) for the first 3 years post-approval, then annually. PSURs in ICH E2C(R2) format accepted in lieu of PADERs by agreement. FAERS database receives spontaneous reports. Post-Marketing Requirements (PMRs) and Commitments (PMCs) tracked publicly.
Unlicensed access
Named Patient Supply	Available	Available
Compassionate Use	Available	Available
Emergency Import	Available	Available
Parallel Import	Not permitted	Not permitted
Clinical trials
CTA approval	Required	Required
Ethics approval	Yes	Yes
CTA timeline	30–60 days	30–30 days
GCP standard	ICH E6(R2/R3) GCP; TFDA Good Clinical Practice (GCP) Guidelines	ICH E6(R3) (adopted via FDA guidance January 2025); 21 CFR 312, 314, 50, 56
Pricing & reimbursement
Price regulation	Regulated	Free pricing
Reference pricing	Yes	No
HTA required	Yes	No
HTA body	Center for Drug Evaluation (CDE) — HTA Division	ICER (Institute for Clinical and Economic Review) — independent, non-binding

Verdict colours indicate lower, moderate, or higher regulatory burden — they're not value judgements on a market.

Authority & dossier

Regulatory authority

TaiwanTFDA
United StatesFDA

English submissions

TaiwanYes
United StatesYes

CTD accepted

TaiwanYes
United StatesYes

eCTD accepted

TaiwanYes
United StatesYes

Reliance pathway

TaiwanAvailable
United StatesNone

Reference agencies

TaiwanFDA, EMA, PMDA, MHRA +3
United States—

Lead pathway (timeline & fees) — New Drug Application (NDA / BLA) — Standard · New Drug Application — 505(b)(1)

Pathway name

TaiwanNew Drug Application (NDA / BLA) — Standard
United StatesNew Drug Application — 505(b)(1)

Approval timeline

Taiwan360–540 days
United States304–365 days

Application fee

TaiwanTWD 720,000
United StatesUSD 4,310,002

Annual renewal

TaiwanTWD 0
United StatesUSD 416,734

Local representative

TaiwanRequired
United StatesNot required

Local manufacturing

TaiwanNot required
United StatesNot required

GMP inspection

TaiwanRequired
United StatesRequired

MAH & local presence

Local entity required

TaiwanYes
United StatesNo

Local responsible person

TaiwanYes
United StatesYes

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 StatesUS Agent: a person residing or maintaining a place of business in the US, designated to act on behalf of the foreign establishment for FDA communications, including notification of inspections.

Accelerated pathways

Designations available

Taiwan3 designations
United States6 designations

Examples

TaiwanPriority Review, Orphan Drug Designation, TFDA–PMDA Parallel Review
United StatesPriority Review, Breakthrough Therapy Designation, Accelerated Approval — Subpart H/E +3

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 StatesFDA classifies post-approval changes as: Annual Reportable, Changes Being Effected (CBE-0 immediate, CBE-30 with 30-day pre-implementation notice), and Prior Approval Supplements (PAS) — the most significant changes requiring FDA approval before implementation. Major manufacturing or labelling changes typically require a PAS.

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 StatesFDA does not require periodic renewal of NDAs or BLAs — approvals remain in effect indefinitely subject to compliance, payment of annual program fees, and post-marketing requirements. Annual reports are required.

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 StatesMandatory expedited reporting of serious unexpected ADRs within 15 calendar days; periodic safety reports (PADERs/PAERs) for the first 3 years post-approval, then annually. PSURs in ICH E2C(R2) format accepted in lieu of PADERs by agreement. FAERS database receives spontaneous reports. Post-Marketing Requirements (PMRs) and Commitments (PMCs) tracked publicly.

Unlicensed access

Named Patient Supply

TaiwanAvailable
United StatesAvailable

Compassionate Use

TaiwanAvailable
United StatesAvailable

Emergency Import

TaiwanAvailable
United StatesAvailable

Parallel Import

TaiwanNot permitted
United StatesNot permitted

Clinical trials

CTA approval

TaiwanRequired
United StatesRequired

Ethics approval

TaiwanYes
United StatesYes

CTA timeline

Taiwan30–60 days
United States30–30 days

GCP standard

TaiwanICH E6(R2/R3) GCP; TFDA Good Clinical Practice (GCP) Guidelines
United StatesICH E6(R3) (adopted via FDA guidance January 2025); 21 CFR 312, 314, 50, 56

Pricing & reimbursement

Price regulation

TaiwanRegulated
United StatesFree pricing

Reference pricing

TaiwanYes
United StatesNo

HTA required

TaiwanYes
United StatesNo

HTA body

TaiwanCenter for Drug Evaluation (CDE) — HTA Division
United StatesICER (Institute for Clinical and Economic Review) — independent, non-binding