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This application is a service of the Singapore Government.

Health Sciences Authority

Overview

As part of HSA’s ongoing initiative to update and streamline the regulatory controls for health products, pharmaceutical products, commonly known as chemical or biologic drugs, are now regulated 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.

Information on HSA’s enforcement, post-market vigilance and compliance activities, as well as product safety information and recalls can be found on this webpage.

Frequently Used Links

BranchInfo

Branch Information

HSA's Enforcement Branch
Information about the Enforcement Branch

HSA's Vigilance and Compliance Branch
Information about the Vigilance and Compliance Branch


safetyinfo

Safety Information

Product Safety Alerts
Important safety messages for Healthcare Professionals on drugs, medical devices and related health products

Dear Healthcare Professional Letters (DHCPL)
Advisory letters to healthcare professionals by HSA, pharmaceuticals and medical device companies

Products Recalls
Listing of products recalled by HSA as part of the Product Quality Surveillance programme

Listing of Safety-related Product Label Amendments
Listing of local package inserts with labelling amendments due to safety-related issues

Adverse Drug Reactions News Bulletin and New Drug Lists
Download PDF versions of Adverse Drug Reaction (ADR) news bulletin and posters for new drugs

Medical Device Alerts
Download PDF versions of Medical Device Alert articles

Glossary Listing by Product
A glossary listing of the safety issues and product recalls related to therapeutic products, complementary medicines and cosmetics.


Updates

Guidance

Product Defect Reporting and Recall Procedures
Guidelines on product defect reporting, recall procedures and reporting forms

Guidance for Industry and Applicants
Guidance for industry on the submission of relevant safety information relating to registered therapeutic products


SafetyReporting
AE3

Safety Reporting

Report Adverse Event
How to report adverse events to the Vigilance and Compliance Branch