§ 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	🇪🇺European Union
Authority & dossier
Regulatory authority	HSA	EMA
English submissions	Yes	Yes
CTD accepted	Yes	Yes
eCTD accepted	Yes	Yes
Reliance pathway	Available	Available
Reference agencies	FDA, EMA (centralised), MHRA, Health Canada +3	—
Lead pathway (timeline & fees) — Full Evaluation Route (NDA) · Centralised Procedure
Pathway name	Full Evaluation Route (NDA)	Centralised Procedure
Approval timeline	270–365 days	210–277 days
Application fee	SGD 110,000	EUR 358,800
Annual renewal	SGD 4,500	EUR 122,500
Local representative	Required	Required
Local manufacturing	Not required	Not required
GMP inspection	Not required	Required
MAH & local presence
Local entity required	Yes	Yes
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.	Qualified Person Responsible for Pharmacovigilance (QPPV) — must reside and operate in the EU/EEA — is responsible for the establishment and maintenance of the pharmacovigilance system. A Qualified Person (QP) in the EU/EEA performs batch certification under Article 51 of Directive 2001/83/EC. Local Contact Person for pharmacovigilance required in each Member State where the product is marketed (since 2012 GVP).
Accelerated pathways
Designations available	3 designations	6 designations
Examples	Priority Review, Project Orbis Participation, Pandemic Special Access Route (PSAR)	Accelerated Assessment, Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +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.	Commission Regulation (EC) 1234/2008 establishes four categories: Type IA (minor — Do and Tell, 12-month notification), Type IAIN (minor — immediate notification), Type IB (minor — Tell, Wait, and Do, 30-day default), Type II (major — prior approval, 60–90 days), and Extensions (Annex I changes — full review). Worksharing procedures consolidate variations across multiple authorisations.
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.	Initial 5-year renewal — application 9 months before expiry. After the first renewal, MA is granted for unlimited duration unless the CHMP/NCA, on justified grounds relating to pharmacovigilance, decides on one additional 5-year renewal.
Pharmacovigilance	Pharmacovigilance under HSA Vigilance & Compliance Branch. PSURs aligned with ICH E2C(R2). Mandatory ICSR reporting via PRISM. Singapore is a WHO-UMC member.	Comprehensive PV framework under Directive 2010/84/EU and Regulation (EU) 1235/2010, codified in Good Pharmacovigilance Practices (GVP). Pharmacovigilance System Master File (PSMF) required. Periodic Safety Update Reports (PSURs) on EU-harmonised birth-date list. Risk Management Plans for all new MAs and significant variations. Suspected serious ADR reporting to EudraVigilance within 15 days. Black triangle (▼) for additional monitoring of selected products.
Unlicensed access
Named Patient Supply	Available	Available
Compassionate Use	Available	Available
Emergency Import	Available	Available
Parallel Import	Permitted	Permitted
Clinical trials
CTA approval	Required	Required
Ethics approval	Yes	Yes
CTA timeline	30–60 days	60–106 days
GCP standard	ICH-GCP	ICH E6(R3) — Commission Regulation (EU) 2024/2748 transposing R3, applicable from 23 July 2025
Pricing & reimbursement
Price regulation	Free pricing	Regulated
Reference pricing	No	Yes
HTA required	Yes	Yes
HTA body	Agency for Care Effectiveness (ACE)	EU HTA Coordination Group (EUnetHTA legacy); national HTA bodies (NICE, HAS, G-BA/IQWiG, AIFA, AEMPS, etc.)

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

Authority & dossier

Regulatory authority

SingaporeHSA
European UnionEMA

English submissions

SingaporeYes
European UnionYes

CTD accepted

SingaporeYes
European UnionYes

eCTD accepted

SingaporeYes
European UnionYes

Reliance pathway

SingaporeAvailable
European UnionAvailable

Reference agencies

SingaporeFDA, EMA (centralised), MHRA, Health Canada +3
European Union—

Lead pathway (timeline & fees) — Full Evaluation Route (NDA) · Centralised Procedure

Pathway name

SingaporeFull Evaluation Route (NDA)
European UnionCentralised Procedure

Approval timeline

Singapore270–365 days
European Union210–277 days

Application fee

SingaporeSGD 110,000
European UnionEUR 358,800

Annual renewal

SingaporeSGD 4,500
European UnionEUR 122,500

Local representative

SingaporeRequired
European UnionRequired

Local manufacturing

SingaporeNot required
European UnionNot required

GMP inspection

SingaporeNot required
European UnionRequired

MAH & local presence

Local entity required

SingaporeYes
European UnionYes

Local responsible person

SingaporeYes
European UnionYes

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.
European UnionQualified Person Responsible for Pharmacovigilance (QPPV) — must reside and operate in the EU/EEA — is responsible for the establishment and maintenance of the pharmacovigilance system. A Qualified Person (QP) in the EU/EEA performs batch certification under Article 51 of Directive 2001/83/EC. Local Contact Person for pharmacovigilance required in each Member State where the product is marketed (since 2012 GVP).

Accelerated pathways

Designations available

Singapore3 designations
European Union6 designations

Examples

SingaporePriority Review, Project Orbis Participation, Pandemic Special Access Route (PSAR)
European UnionAccelerated Assessment, Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +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.
European UnionCommission Regulation (EC) 1234/2008 establishes four categories: Type IA (minor — Do and Tell, 12-month notification), Type IAIN (minor — immediate notification), Type IB (minor — Tell, Wait, and Do, 30-day default), Type II (major — prior approval, 60–90 days), and Extensions (Annex I changes — full review). Worksharing procedures consolidate variations across multiple authorisations.

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.
European UnionInitial 5-year renewal — application 9 months before expiry. After the first renewal, MA is granted for unlimited duration unless the CHMP/NCA, on justified grounds relating to pharmacovigilance, decides on one additional 5-year renewal.

Pharmacovigilance

SingaporePharmacovigilance under HSA Vigilance & Compliance Branch. PSURs aligned with ICH E2C(R2). Mandatory ICSR reporting via PRISM. Singapore is a WHO-UMC member.
European UnionComprehensive PV framework under Directive 2010/84/EU and Regulation (EU) 1235/2010, codified in Good Pharmacovigilance Practices (GVP). Pharmacovigilance System Master File (PSMF) required. Periodic Safety Update Reports (PSURs) on EU-harmonised birth-date list. Risk Management Plans for all new MAs and significant variations. Suspected serious ADR reporting to EudraVigilance within 15 days. Black triangle (▼) for additional monitoring of selected products.

Unlicensed access

Named Patient Supply

SingaporeAvailable
European UnionAvailable

Compassionate Use

SingaporeAvailable
European UnionAvailable

Emergency Import

SingaporeAvailable
European UnionAvailable

Parallel Import

SingaporePermitted
European UnionPermitted

Clinical trials

CTA approval

SingaporeRequired
European UnionRequired

Ethics approval

SingaporeYes
European UnionYes

CTA timeline

Singapore30–60 days
European Union60–106 days

GCP standard

SingaporeICH-GCP
European UnionICH E6(R3) — Commission Regulation (EU) 2024/2748 transposing R3, applicable from 23 July 2025

Pricing & reimbursement

Price regulation

SingaporeFree pricing
European UnionRegulated

Reference pricing

SingaporeNo
European UnionYes

HTA required

SingaporeYes
European UnionYes

HTA body

SingaporeAgency for Care Effectiveness (ACE)
European UnionEU HTA Coordination Group (EUnetHTA legacy); national HTA bodies (NICE, HAS, G-BA/IQWiG, AIFA, AEMPS, etc.)