Singapore's Health Sciences Authority (HSA)

Health Product Registration Group (HPRG) and Therapeutic Products Division (TPD)

The Health Product Regulation Group (HPRG) is the sector of the Health Sciences Authority (HSA) dedicated to the regulation of pharmaceuticals and medical devices. The Therapeutic Products Division (TPD) is a special division of the HPRG, and is comprised of the Clinical Trials Branch, the Pharmaceuticals and Biologics Branch and the Medical Device Branch.

The Pharmaceuticals and Biologics Branch is responsible for the registration approval of pharmaceuticals and the continual post-market review of registered pharmaceuticals. It also reviews and approves product licenses and import/export licenses.

The Medical Device Branch is responsible for pre-market and post-market regulation of medical devices, including product licensing. As of October 2009, full implementation of medical device regulations is in effect. The manufacture, import and wholesale by unlicensed parties is prohibited.

The HPRG also has the authority to order recalls in the event of a serious accident or safety threats. The TPD supports the Medicines Advisory Committee (MAC), and provides consultative services for the Medical Clinical Research Committee (MCRC).

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