Singapore GMP Standard
Singapore’s Health Sciences Authority (HSA) regulates the manufacture of therapeutic products under the Health Products Act and the Health Products (Therapeutic Products) Regulations 2016, requiring a manufacturer’s licence. As a PIC/S participating authority, HSA adopts the current version of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE 009) as its GMP standard, and assesses overseas manufacturers for conformance to PE 009 through documentary evidence or on-site audit.
What this does not cover
stated in the document's own scope- Adopts the PIC/S PE 009 GMP standard rather than maintaining a separate Singapore GMP code.
- Covers therapeutic products; Chinese Proprietary Medicines are regulated through a separate HSA framework.
- Sets manufacturing GMP, not product registration, which HSA governs through its own therapeutic-product registration process.
Always verify against the current published text before relying on it for a submission or inspection.
Overview
Singapore’s Health Sciences Authority (HSA) regulates the manufacture of therapeutic products and requires a manufacturer’s licence for local production. As a participating authority of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), HSA adopts the current version of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE 009) as its GMP standard, so a Singapore site works to the same harmonised text used across the PIC/S membership. Overseas manufacturers of products registered in Singapore are assessed for conformance to PE 009 through documentary evidence or an on-site audit.
Scope & applicability
Manufacturers of therapeutic products supplying Singapore, and overseas manufacturers of products registered there. HSA also runs a separate framework for Chinese Proprietary Medicines.
Legal basis & how it acquires force
Manufacturing of therapeutic products is regulated under the Health Products Act and its subsidiary legislation, principally the Health Products (Therapeutic Products) Regulations 2016. These are binding instruments for the Singapore market: a manufacturer’s licence is required, and it is conditional on conformance to the PIC/S GMP standard HSA adopts. HSA is the competent authority that issues the licence, assesses GMP evidence, and conducts inspections.
Document structure
| Part | Covers |
|---|---|
| Licensing framework | The manufacturer’s licence and dealer’s licence required under the Health Products Act |
| Adopted GMP standard (PE 009 Part I) | The basic requirements for medicinal products — quality system, personnel, premises, documentation, production, and quality control |
| Adopted GMP standard (PE 009 Part II) | Basic requirements for active substances used as starting materials |
| Annexes | The PIC/S annexes on sterile products, qualification and validation, computerised systems, and related topics |
| Overseas GMP conformity | Assessment of overseas manufacturers by documentary evidence or on-site audit |
Key requirements
- Hold an HSA manufacturer’s licence for therapeutic-product manufacture.
- Conform to the current PIC/S PE 009 GMP Guide adopted by HSA.
- Provide acceptable GMP evidence — a valid PIC/S-authority certificate or an HSA audit — for overseas sites.
Implementation tips
- A valid GMP certificate from a PIC/S member authority can satisfy HSA’s conformity assessment without a separate Singapore audit.
Revision notes
The Health Products (Therapeutic Products) Regulations 2016 took effect on 1 November 2016; HSA tracks the current PE 009 revision.
Where this control fails
live FDA enforcementLive FDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
International alignment
Because HSA adopts PE 009 directly, Singapore GMP is harmonised with the wider PIC/S membership and, through it, with the EU GMP Guide the PIC/S text mirrors. HSA recognises evidence of GMP compliance from other PIC/S member authorities: where a valid GMP certificate or inspection report from a PIC/S authority is acceptable, a separate HSA audit may not be necessary. This reliance is the practical benefit of Singapore’s PIC/S participation.
HSA GMP (PIC/S PE 009): frequently asked questions
Quick answers to common questions about HSA GMP (PIC/S PE 009).
What GMP standard does Singapore use?
HSA adopts the current version of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE 009) as Singapore’s GMP standard, so local and overseas sites are assessed against PE 009 rather than a separate national code.
Which law governs medicine manufacture in Singapore?
The Health Products Act and its subsidiary legislation, principally the Health Products (Therapeutic Products) Regulations 2016, under which a manufacturer’s licence is required.
Will HSA accept a GMP certificate from another country?
It can. HSA recognises acceptable GMP evidence from other PIC/S member authorities, and where a valid certificate or inspection report is accepted, a separate HSA on-site audit may not be needed.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.