Therapeutic products: New Regulations & Clinical Trial of medical device: CRM replacing former t

The Health Sciences Authority of Singapore (HSA) introduced the Health Products Act (HPA) in 2007 in which their aim is to consolidate and streamline the regulatory controls of health products under one single Act. This was done in strategic phases so as to cover a range of health products.

According to the latest information by HSA, Pharmaceutical products, also commonly known as chemical or biologic drugs, will now be regulated as “therapeutic products” in the HPA. Moving forward, the existing controls namely the Medicines Act (MA) and Poisons Act (PA) will no longer be applicable to pharmaceutical products. HSA has listed the following six pieces of legislation that will be introduced in the HPA for the regulation of therapeutic products:

  • Health Products Act (Amendment of First Schedule) Order 2016

  • Health Products (Therapeutic Products) Regulations 2016

  • Health Products (Clinical Trials) Regulations 2016

  • Health Products (Therapeutic Products as Clinical Research Materials) Regulations 2016

  • Health Products (Advertisement of Therapeutic Products) Regulations 2016

  • Health Products (Licensing of Retail Pharmacies) Regulations 2016

Similarly, the following three pieces of legislation for the controls of medicinal products (MP) under MA and medical devices (MD) under HPA, used in clinical trials/clinical research are updated to ensure that the controls are aligned with the controls of TP under the HPA:

  • Medicines (Clinical Trials) Regulations 2016

  • Medicines (Medicinal Products as Clinical Research Materials) Regulations 2016

  • Health Products (Medical Devices) (Amendment) Regulations 2016

The legislation will be implemented to streamline and simplify the regulatory approach for the import and supply of therapeutic products (TP), medicinal products (MP) and medical devices (MD) for use in clinical research, including regulated clinical trials. These products referred to as “Clinical Research Materials*” (CRM), replacing the former term “Clinical Trial Material”.

HSA has finalised the legislations following public consultations and face-to-face briefings conducted with representatives from the industry, healthcare institutions and healthcare professionals. These legislations were subsequently gazetted on 15 July 2016 and will take effect on 1 November 2016.

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