Singapore Biosimilars Guideline

September 19, 2011 6:27 AM

Health Sciences Authority (HSA) was formed in April 2001 with the integration of 5 highly specialised agencies under the Ministry of Health; Centre for Drug Evaluation, Institute of Science and Forensic Medicine, National Pharmaceutical Administration, Product Regulation Department and Singapore Blood Transfusion Service.

The organisation serves three key functions: It is the national regulator for health products; it secures the national blood suppy through its operation of the national blood bank; and it represents the national expertise in forensic medicine, forensic science and analytical chemistry testing capabilities.

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

The biosimilars guideline in Singapore is named “Guidance on registration of similar biological products ” and 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.

Guidance on medicinal product registration in Singapore can be accessed from here

Appendix 17 covers all biosimilar products and can be accessed from here.


Source: HSA

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