Regulation of Therapeutic Products under the Health Products Act
The Regulation of Therapeutic Products under the Health Products Act is now in effect (as of 1 November 2016).
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:
- Health Products Act (Amendment of First Schedule) Order 2016
- definition of "Therapeutic Products"
- 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
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:
- Medicines (Clinical Trials) Regulations 2016
- Medicines (Medicinal Products as Clinical Research Materials) Regulations 2016
- Health Products (Medical Devices) (Amendment) Regulations 2016
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?
The following sections provide some information on the respective legislation and key changes. This should always be read in conjunction with the respective pieces of legislation.
|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?
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’)
|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