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This application is a service of the Singapore Government.

Health Sciences Authority

Guidance for Industry and Applicants

AE3

As part of HSA’s ongoing initiative to update and streamline the regulatory controls for health products, pharmaceutical products, commonly known as chemical and biologic drugs, have been introduced as “Therapeutic Products” under the Health Products Act (HPA).

The regulatory controls of the HPA on TP is now in effect (as of 1 November 2016). Please click here for an overview of the port-over exercise and its implementation.

Please refer to the guidelines below for the requirements on post-market vigilance, product defect reporting and product recalls for therapeutic products.

 

1. Post-Marketing Vigilance Requirements for Therapeutic Products

1a. Download.IconPdf Guidance for Industry- Post-Marketing Vigilance Requirements for Therapeutic Products (November 2016) ~New
[File Type: PDF | Size: 501 Kb] 

Note: The purpose of this document is to provide guidance on the reporting and submission of relevant safety information of registered therapeutic products to the Vigilance and Compliance Branch of HSA in accordance with the Health Products Act and Health Products (Therapeutics Products) Regulations 2016.

 

1b. Download.IconPdf Risk Management Plan Industry Consultation_FAQs_November 2016
[File Type: PDF | Size: 275 Kb]

Note: This document applies to product registrants who are responsible for introducing registered therapeutic products into Singapore. It provides guidance to product registrants on the submission of relevant safety information relating to registered therapeutic products to the Vigilance and Compliance Branch. It addresses the types of documents to be submitted, the timelines and the requirements for reporting drug safety information.

 

2. Reporting of Therapeutic Product Defects and Recall of Therapeutic Products

2a. Download.IconPdf Guidance for Industry- Reporting of Therapeutic Product Defects and Recall of Therapeutic Products (November 2016) ~New
[File Type: PDF  | Size: 300kb]

Note: The purpose of this document is to provide guidance on reporting product defects (“defects”) and/or product recall (“recall”) of therapeutic products to the Vigilance and Compliance Branch of HSA in accordance with the Health Products Act and Health Products (Therapeutic Products) Regulations 2016.

 

2b. Download.IconPdf FAQ on reporting of therapeutic product defects and recall of therapeutic products (November 2016) ~New
[File Type: PDF  | Size: 99kb]

 

Company are advised to download the relevant reporting form below and submit the completed form and any other accompanying documents as specified in the guidance to: 

Vigilance and Compliance Branch

Email: hsa_productdefect@hsa.gov.sg

 

Download Adobe Acrobat Reader to view the above PDF documents.

 

Contact Us

If you need further information regarding AE reporting, please contact the Vigilance and Compliance Branch.

For enquiries and feedback on Therapeutic Products (TP) Regulations Port-over, please contact:
Email: HSA_TPPortOver@hsa.gov.sg