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Health Sciences Authority
HSA Updates

HSA Updates on the Transfer of Controls of Pharmaceutical Products to Health Products Act

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21 July 2016

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With effect from 1 November 2016, the Health Sciences Authority (HSA) will be streamlining and transferring the existing regulatory controls for pharmaceutical products under the Medicines Act (MA) and Poisons Act into a single legislation, the Health Products Act (HPA).

2    Under the HPA, pharmaceutical products, or conventional chemical and biologic drugs, will be referred to as “therapeutic products” (TP), and regulatory controls will be stratified based on the risk profiles of the products. The new Regulations will cater to different operational and business models in the rapidly evolving pharmaceutical landscape, while remaining relevant and adequate to safeguard public health and facilitate timely access to TP.

3    A total of six pieces of subsidiary legislation for the controls of therapeutic products under the HPA were finalised and gazetted on 15 July 2016. HSA had considered responses from stakeholders through two public consultation exercises and several focus-group discussions held over the proposed regulatory controls of TP under the HPA. The six pieces of subsidiary legislation under the HPA are as follows:

Correspondingly, two pieces of subsidiary legislation for the controls of other medicinal products under MA and one piece of subsidiary legislation for the controls of medical devices under HPA used in clinical trials were updated and gazetted on 15 July 2016. This is to ensure that the controls are aligned with the controls for TP under the HPA. The three pieces of subsidiary legislation are as follows:

4    For more details on the feedback gathered during the 2 public consultation exercises, please refer to the Conclusion to the Public Consultation report.  

5    To facilitate the transition to the control of TP under the HPA on 1 November 2016, HSA will be organising workshops for the industry and affected stakeholders in the coming weeks. Interested parties may look out for the announcement of these workshops on the HSA website or register their email address with HSA to receive updates. They may also refer to this link for more information on the transfer of regulatory controls of TP to HPA and the related legislation.

HEALTH SCIENCES AUTHORITY
SINGAPORE
20 JULY 2016  

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