Health Sciences Authority
Singapore regulator; regulates therapeutic products under the Health Products Act and adopts the PIC/S PE 009 GMP Guide as its manufacturing standard.
What this page does not claim
SPEQ curates and cross-references these bodies. It is not affiliated with, accredited by, or endorsed by any of them, and a count of decoded standards is a measure of SPEQ’s coverage, not of a body’s importance.
WHAT HSA COVERS
Singapore’s Health Sciences Authority (HSA) regulates therapeutic products, medical devices, and related health products. Manufacture of therapeutic products is governed by the Health Products Act and the Health Products (Therapeutic Products) Regulations 2016, under which a manufacturer’s licence is required. As a PIC/S participating authority, HSA adopts the current PIC/S PE 009 GMP Guide as its manufacturing standard.
WHAT HSA PUBLISHES
- 01The Health Products Act and the Health Products (Therapeutic Products) Regulations 2016
- 02Guidance on GMP and GDP standards and on GMP conformity assessment of overseas manufacturers
- 03Manufacturer’s, importer’s, and wholesaler’s (dealer’s) licences
- 04Therapeutic-product registration decisions and safety communications
- 05The separate framework for Chinese Proprietary Medicines
HOW ITS REQUIREMENTS BITE
HSA licenses local manufacturers against the adopted PIC/S GMP standard and assesses overseas manufacturers of registered products through a GMP conformity assessment — either documentary evidence or an on-site audit. Where a valid GMP certificate or inspection report from a PIC/S member authority is acceptable, a separate HSA audit may not be necessary, so much of HSA’s oversight of foreign sites operates through reliance on the wider PIC/S network.
What practitioners get wrong
- HSA adopts PE 009 directly — there is no separate Singapore GMP code, so work to the current PIC/S text.
- A valid GMP certificate from a PIC/S member authority can satisfy HSA’s conformity assessment without a fresh Singapore audit.
- Therapeutic products and Chinese Proprietary Medicines run on different frameworks; confirm which applies before assuming requirements.
- GMP conformity is assessed for overseas sites of registered products, so a manufacturer outside Singapore is still within scope.
What an inspection under this authority actually probes
WHERE IT SITS INTERNATIONALLY
As a PIC/S participating authority, HSA adopts the PE 009 GMP Guide, harmonising Singapore GMP with the PIC/S membership and, through it, with EU GMP. That membership underpins HSA’s reliance on GMP evidence from other PIC/S authorities.
HSA STANDARDS SPEQ DECODES · 1
DISCIPLINES IN HSA’S REMIT
HSA: frequently asked questions
Reference answers on Health Sciences Authority’s mandate, what it publishes, and how its requirements acquire force.
What GMP standard does Singapore apply?
HSA adopts the current version of the PIC/S PE 009 Guide to Good Manufacturing Practice 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 the Health Products (Therapeutic Products) Regulations 2016, under which a manufacturer’s licence is required.
Will HSA accept a foreign GMP certificate?
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.