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This application is a service of the Singapore Government.

Health Sciences Authority

Regulation of Therapeutic Products under the Health Products Act

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The Regulation of Therapeutic Products under the Health Products Act is now in effect (as of 1 November 2016).

BACKGROUND

The Health Products Act (HPA) was introduced in 2007 with the aim to consolidate and streamline the regulatory controls of health products under one single Act. The consolidation is done in phases to cover a range of health products.

Pharmaceutical products, commonly known as chemical or biologic drugs, are now regulated as “Therapeutic Products” under the HPA, replacing the controls under the Medicines Act (MA) and Poisons Act (PA).

The following six pieces of legislation introduced under the HPA for the regulation of therapeutic products and clinical trials were published on 15 July 2016:

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

For the list of subsidiary legislation under the HPA, MA, and PA, please refer to the Legislation page on the HSA Website.

 

WHAT HAS CHANGED?

WHAT ARE THE IMPORTANT DATES TO TAKE NOTE OF?

S/N Announcement Date
1 Gazetting of the legislation for Therapeutic Products under the Health Products Act 15 July 2016
2 Briefing Session on the regulation of therapeutic products under Health Products Act 

 

Click here to download the presentation materials and find out more information on the event.

19 Aug 2016
3 Implementation of the new regulatory controls for therapeutic products under the Health Products Act 1 November 2016

 

WHERE CAN I FIND MORE INFORMATION?

GUIDANCE DOCUMENTS

The following table lists the key guidance documents that were introduced or updated to align to the Therapeutic Products Regulations under the Health Products Act. Please note that the list is NOT exhaustive and all guidance should be read in conjunction with the relevant legislation in Singapore (see ‘Legislation’)

S/N Guidance Document Type Remarks
Clinical Trials
1 Guidance on Determining Whether a Clinical Trial Requires a Clinical Trial Authorisation (CTA), Clinical Trial Notification (CTN) or Clinical Trial Certificate (CTC) New Click here to view document
2 Guidance on Regulatory Requirements for New Applications and Subsequent Submissions New Click here to view document
3 Guidance on Determining Whether an Amendment to a Clinical Trial is a Substantial Amendment New Click here to view document
4 Guidance on Clinical Research Materials New Click here to view document
5 Guidance on Labelling of Therapeutic and Medicinal Products Used in Clinical Trials New Click here to view document
6 Guidance on Informed Consent for Vulnerable Subjects New Click here to view document
Therapeutic Products Registration
7 Guidance on Therapeutic Products Registration in Singapore Updated Click here to view document
8 Guidance for Change of Registrant for Registered Therapeutic Product New Click here to view document
9 Guidance for Retention of Therapeutic Product on the Product Register New Click here to view document
Dealings (Import, Wholesale, Distribution) in Therapeutic Products
10 Guidance Notes on Duties of Responsible Persons Named in the Importer’s Licence and Wholesaler’s Licence New Click here to view document
11 Guidance Notes on Supply of Registered General Sale List (GSL) Therapeutic Products and Other Medicinal Products via Automatic Vending Machines New Click here to view document
12 Guidance for Application to Import a Therapeutic Product on Consignment Basis New Click here to view document
13 Guidance on Import and Supply of an Unregistered Therapeutic Product for Patients’ Use New Click here to view document
Therapeutic Products Advertisements and Post-Market Surveillance
14 Explanatory Guidance to The Health Products (Advertisement of Therapeutic Products) Regulations 2016 New Click here to view the document
15 Guidance for Industry- Post-Marketing Vigilance Requirements for Therapeutic Products Updated Click here to view document
16 Guidance for Industry– Reporting of Therapeutic Product Defects and Recall of Therapeutic Products  New Click here to view document

 

WHO CAN I CONTACT FOR FURTHER CLARIFICATION?

For enquiries and feedback, please email to us at HSA_TPPortOver@hsa.gov.sg