Safety notification to HSA
Find out when submission of a safety notification is required for registered therapeutic products and CTGTP.
Last updated 13 March 2026
The registrant must notify HSA of actions taken by HSA's reference drug regulatory agencies or the registrant to address significant safety issues which may influence the overall benefit-risk profile of the product as soon as possible.
Examples of such actions include:
Update to warnings or safety information in the overseas product labelling requested by HSA's reference drug regulatory agencies, including removal of approved indications
Company-initiated risk minimisation measures related to newly emerging safety issues that were not mandated by HSA, e.g. dissemination of local Dear Healthcare Professional Letter
Product withdrawal/suspension due to safety concerns
Failure to obtain a product registration renewal due to safety reasons
Ongoing assessments for potential safety signals with no interim measures planned by the registrant or HSA's reference drug regulatory agencies do not need to be notified to HSA. This could include requests by the reference agency to perform a cumulative review of a potential signal.
The safety notification should describe the safety-related reasons that led to the actions being taken, with supporting documents where appropriate. Each notification should be accompanied by the registrant's assessment on the significance of the safety issue in the local context and recommendation(s) on follow-up action(s) to be undertaken locally. If the assessment by the reference agency or registrant is still ongoing, the anticipated timelines for the assessment outcomes should be provided in the interim, followed by the final outcomes when available.
Any intention of voluntary local withdrawal/discontinuation of a registered product from the market by the registrant arising from safety issues should be discussed with HSA at an early stage.