Singapore guidelines for biosimilars Posted 29/07/2011

Last update: 3 August 2012 

Since April 2001, the Health Sciences Authority (HSA) (Chinese: 卫生科学局), 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 (HPRG) 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 Generics and Biosimilars Branch (GBB) of the HPRG is responsible for the registration of generic and biosimilar medicines and the continual review of approved generics and biosimilars.

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.

1.  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 17: Guidance on registration of similar biological products in Singapore
Appendix 17 covers all biosimilar products
Effective date: 1 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

2.  Revisions to overarching guidelines
The Pharmaceutics & Biologics Branch (PBB) and the GBB held the 2nd HPRG Joint Regulatory Workshop on 15 February 2012, and as a result of the session on Regulatory Controls of Medicinal Products updates to the overarching guidelines were made in order to better reflect the current registration environment, provide greater clarity to the registration requirements and to facilitate reduction in the number of queries and/or input requests during the screening process.

Revision to Guidance on Medicinal Product Registration in Singapore
Effective date: March 2012
http://www.hsa.gov.sg/publish/etc/medialib/hsa_library/health_products_regulation/western_medicines/files_guidelines.Par.59682.File.dat/Announcement%20-%20Revision%20to%20Guidance%20on%20Medicinal%20Product%20Registration%20in%20Singapore%20(Mar%202012).pdf

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Singapore guidelines for generics

Source: HSA

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