Singapore guidelines for biosimilars Posted 29/07/2011
Since April 2001, the Health Sciences Authority (HSA) (Chinese: 卫生科学局), under the under the authority of the Ministry of Health of the Singapore Government, has been the authority that oversees all drug manufacturing, trade, and registration in Singapore.
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. Guidance on registration of similar biological products in Singapore was published by the HSA in August 2009. This was added as Appendix 17 to the ‘Guidance on Medicinal Product Registration in Singapore’ in April 2011.
Overarching guidelines
Appendix 17: Guidance on registration of similar biological products in Singapore Related article
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 17 covers all biosimilar products
April 2011
www.hsa.gov.sg/publish/etc/medialib/hsa_library/health_products_regulation/western_medicines/files_guidelines.Par.63688.File.dat/Appendix%2017_Guidance%20on%20Registration%20of%20Similar%20Biological%20Products%20in%20Singapore%202011.pdf
Source: HSA