§ 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 States
Authority & dossier
Regulatory authority	DAV	FDA
English submissions	Yes	Yes
CTD accepted	Yes	Yes
eCTD accepted	No	Yes
Reliance pathway	Available	None
Reference agencies	FDA (US), EMA, MHRA (UK), Health Canada +4	—
Lead pathway (timeline & fees) — New Drug Registration — Standard Visa · New Drug Application — 505(b)(1)
Pathway name	New Drug Registration — Standard Visa	New Drug Application — 505(b)(1)
Approval timeline	270–540 days	304–365 days
Application fee	VND 11,000,000	USD 4,310,002
Annual renewal	VND 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	Visa holders must designate a registered pharmacist (Chief Pharmacist) responsible for quality and pharmacovigilance, and a contact for the National DI&ADR Centre.	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	2 designations	6 designations
Examples	Public Health Emergency / Conditional Visa, Auto-extension of Marketing Authorisation	Priority Review, Breakthrough Therapy Designation, Accelerated Approval — Subpart H/E +3
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.	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	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.	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	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.	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	60–120 days	30–30 days
GCP standard	ICH E6(R2) GCP; MoH Vietnamese 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	No	No
HTA body	MoH Reimbursement Drug List Council (HTA capability developing — Health Strategy and Policy Institute, HSPI)	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

VietnamDAV
United StatesFDA

English submissions

VietnamYes
United StatesYes

CTD accepted

VietnamYes
United StatesYes

eCTD accepted

VietnamNo
United StatesYes

Reliance pathway

VietnamAvailable
United StatesNone

Reference agencies

VietnamFDA (US), EMA, MHRA (UK), Health Canada +4
United States—

Lead pathway (timeline & fees) — New Drug Registration — Standard Visa · New Drug Application — 505(b)(1)

Pathway name

VietnamNew Drug Registration — Standard Visa
United StatesNew Drug Application — 505(b)(1)

Approval timeline

Vietnam270–540 days
United States304–365 days

Application fee

VietnamVND 11,000,000
United StatesUSD 4,310,002

Annual renewal

VietnamVND 0
United StatesUSD 416,734

Local representative

VietnamRequired
United StatesNot required

Local manufacturing

VietnamNot required
United StatesNot required

GMP inspection

VietnamRequired
United StatesRequired

MAH & local presence

Local entity required

VietnamYes
United StatesNo

Local responsible person

VietnamYes
United StatesYes

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 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

Vietnam2 designations
United States6 designations

Examples

VietnamPublic Health Emergency / Conditional Visa, Auto-extension of Marketing Authorisation
United StatesPriority Review, Breakthrough Therapy Designation, Accelerated Approval — Subpart H/E +3

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 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

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 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

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 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

VietnamAvailable
United StatesAvailable

Compassionate Use

VietnamAvailable
United StatesAvailable

Emergency Import

VietnamAvailable
United StatesAvailable

Parallel Import

VietnamNot permitted
United StatesNot permitted

Clinical trials

CTA approval

VietnamRequired
United StatesRequired

Ethics approval

VietnamYes
United StatesYes

CTA timeline

Vietnam60–120 days
United States30–30 days

GCP standard

VietnamICH E6(R2) GCP; MoH Vietnamese GCP guidelines
United StatesICH E6(R3) (adopted via FDA guidance January 2025); 21 CFR 312, 314, 50, 56

Pricing & reimbursement

Price regulation

VietnamRegulated
United StatesFree pricing

Reference pricing

VietnamYes
United StatesNo

HTA required

VietnamNo
United StatesNo

HTA body

VietnamMoH Reimbursement Drug List Council (HTA capability developing — Health Strategy and Policy Institute, HSPI)
United StatesICER (Institute for Clinical and Economic Review) — independent, non-binding