§ 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	🇸🇬Singapore	🇺🇸United States
Authority & dossier
Regulatory authority	HSA	FDA
English submissions	Yes	Yes
CTD accepted	Yes	Yes
eCTD accepted	Yes	Yes
Reliance pathway	Available	None
Reference agencies	FDA, EMA (centralised), MHRA, Health Canada +3	—
Lead pathway (timeline & fees) — Full Evaluation Route (NDA) · New Drug Application — 505(b)(1)
Pathway name	Full Evaluation Route (NDA)	New Drug Application — 505(b)(1)
Approval timeline	270–365 days	304–365 days
Application fee	SGD 110,000	USD 4,310,002
Annual renewal	SGD 4,500	USD 416,734
Local representative	Required	Not required
Local manufacturing	Not required	Not required
GMP inspection	Not required	Required
MAH & local presence
Local entity required	Yes	No
Local responsible person	Yes	Yes
RP role	A Qualified Person responsible for pharmacovigilance and a Recall Coordinator must be designated by the Registrant. Registered Pharmacist required for the Dealer's Licence.	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, Project Orbis Participation, Pandemic Special Access Route (PSAR)	Priority Review, Breakthrough Therapy Designation, Accelerated Approval — Subpart H/E +3
Post-approval lifecycle
Variations framework	Post-approval changes classified as Major Variation Application (MAV-1, MAV-2), Minor Variation Application (MIV), and Notifications, broadly aligned with EU Type IA/IB/II framework. ASEAN ACTR (Common Technical Requirements) variations classification adopted.	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	Marketing authorisations valid initially for 1 year (provisional) or 5 years (full); renewal application 6 months before expiry. Most products renewed for indefinite period after first renewal.	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	Pharmacovigilance under HSA Vigilance & Compliance Branch. PSURs aligned with ICH E2C(R2). Mandatory ICSR reporting via PRISM. Singapore is a WHO-UMC member.	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	Permitted	Not permitted
Clinical trials
CTA approval	Required	Required
Ethics approval	Yes	Yes
CTA timeline	30–60 days	30–30 days
GCP standard	ICH-GCP	ICH E6(R3) (adopted via FDA guidance January 2025); 21 CFR 312, 314, 50, 56
Pricing & reimbursement
Price regulation	Free pricing	Free pricing
Reference pricing	No	No
HTA required	Yes	No
HTA body	Agency for Care Effectiveness (ACE)	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

SingaporeHSA
United StatesFDA

English submissions

SingaporeYes
United StatesYes

CTD accepted

SingaporeYes
United StatesYes

eCTD accepted

SingaporeYes
United StatesYes

Reliance pathway

SingaporeAvailable
United StatesNone

Reference agencies

SingaporeFDA, EMA (centralised), MHRA, Health Canada +3
United States—

Lead pathway (timeline & fees) — Full Evaluation Route (NDA) · New Drug Application — 505(b)(1)

Pathway name

SingaporeFull Evaluation Route (NDA)
United StatesNew Drug Application — 505(b)(1)

Approval timeline

Singapore270–365 days
United States304–365 days

Application fee

SingaporeSGD 110,000
United StatesUSD 4,310,002

Annual renewal

SingaporeSGD 4,500
United StatesUSD 416,734

Local representative

SingaporeRequired
United StatesNot required

Local manufacturing

SingaporeNot required
United StatesNot required

GMP inspection

SingaporeNot required
United StatesRequired

MAH & local presence

Local entity required

SingaporeYes
United StatesNo

Local responsible person

SingaporeYes
United StatesYes

RP role

SingaporeA Qualified Person responsible for pharmacovigilance and a Recall Coordinator must be designated by the Registrant. Registered Pharmacist required for the Dealer's Licence.
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

Singapore3 designations
United States6 designations

Examples

SingaporePriority Review, Project Orbis Participation, Pandemic Special Access Route (PSAR)
United StatesPriority Review, Breakthrough Therapy Designation, Accelerated Approval — Subpart H/E +3

Post-approval lifecycle

Variations framework

SingaporePost-approval changes classified as Major Variation Application (MAV-1, MAV-2), Minor Variation Application (MIV), and Notifications, broadly aligned with EU Type IA/IB/II framework. ASEAN ACTR (Common Technical Requirements) variations classification adopted.
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

SingaporeMarketing authorisations valid initially for 1 year (provisional) or 5 years (full); renewal application 6 months before expiry. Most products renewed for indefinite period after first renewal.
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

SingaporePharmacovigilance under HSA Vigilance & Compliance Branch. PSURs aligned with ICH E2C(R2). Mandatory ICSR reporting via PRISM. Singapore is a WHO-UMC member.
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

SingaporeAvailable
United StatesAvailable

Compassionate Use

SingaporeAvailable
United StatesAvailable

Emergency Import

SingaporeAvailable
United StatesAvailable

Parallel Import

SingaporePermitted
United StatesNot permitted

Clinical trials

CTA approval

SingaporeRequired
United StatesRequired

Ethics approval

SingaporeYes
United StatesYes

CTA timeline

Singapore30–60 days
United States30–30 days

GCP standard

SingaporeICH-GCP
United StatesICH E6(R3) (adopted via FDA guidance January 2025); 21 CFR 312, 314, 50, 56

Pricing & reimbursement

Price regulation

SingaporeFree pricing
United StatesFree pricing

Reference pricing

SingaporeNo
United StatesNo

HTA required

SingaporeYes
United StatesNo

HTA body

SingaporeAgency for Care Effectiveness (ACE)
United StatesICER (Institute for Clinical and Economic Review) — independent, non-binding