HSA is responsible for ensuring that the quality, safety and efficacy of western medicines in Singapore meet internationally benchmarked standards and consumers have timely access to medicines.

The Health Products Regulation Group of the HSA ensures that drugs, innovative therapeutics, medical devices and health-related products in Singapore are wisely regulated to meet appropriate standards of safety, quality and efficacy. The agency also contributes to the formulation of national drug policies.

The Medicines Act requires all medicinal products sold in Singapore and manufactured locally for export to be licensed with the Health Products Regulation Group, HSA.

In Singapore, guidelines for generic products were added as Appendix 12 to the ‘Guidance on Medicinal Product Registration in Singapore’ in April 2011.

Overarching guidelines
Guidance on medicinal product registration in Singapore
Effective date: 1 April 2011
www.hsa.gov.sg/publish/etc/medialib/hsa_library/health_products_regulation/western_medicines/files_guidelines.Par.22361.File.dat/Guidance%20on%20Medicinal%20Product%20Registration%20in%20Singapore%202011%20(COMPLETE).pdf

Appendix 12: Product interchangeability and biowaver request for chemical generic drug applications
Appendix 12 covers all generic products
April 2011
www.hsa.gov.sg/publish/etc/medialib/hsa_library/health_products_regulation/western_medicines/files_guidelines.Par.55334.File.dat/Appendix%2012_Product%20Interchangeability%20and%20Biowaiver%20Request%20for%20Chemical%20Generic%20Drug%20Applications%202011.pdf

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