Singapore guidelines for generics

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Singapore guidelines for generics

Home/Guidelines | Posted 05/08/2011 0 Post your comment

Last update: 10 August 2012

Since April 2001, the Health Sciences Authority (HSA, 卫生科学局), under the authority of the Ministry of Health of the Singapore Government, has been the Singapore authority that oversees all drug manufacturing, trade, and registration.

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.

In Singapore, guidelines for generic products were added as Appendix 12 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 12: Product interchangeability and biowaver request for chemical generic drug applications
Appendix 12 covers all generic products
Effective Date: 1 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

2. Revisions to overarching guidelines
The Pharmaceutics & Biologics Branch (PBB) and the GBB held the 2^nd 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 biosimilars

Source: HSA