Report adverse events
It is important to report adverse events associated with health products. Find out how to report them to HSA.
How to report
You are encouraged to report to us as soon as you are made aware of the adverse events, using one of the following methods:
Online submission
Manual submission
Product types | Reporting forms |
|---|---|
Therapeutic products (other than cell, tissue and gene therapy products) | |
Complementary health products such as:
| |
Cell, tissue and gene therapy products | |
Cosmetic products (for company reporting only) |
Complete the relevant form above and submit to us accordingly.
Information on adverse event reporting
For therapeutic product companies
Therapeutic product importers, manufacturers, suppliers and registrants are required to report all serious adverse events of their products.For cell, tissue or gene therapy product (CTGTP) companies
CTGTP importers, manufacturers, suppliers and registrants are required to report all serious adverse events of their productsFor medical device companies
All companies dealing in medical devices including importers, manufacturers, suppliers and registrants are required to report adverse events of their products.For clinical trials
The clinical trial sponsor is required to report adverse events involving therapeutic products, CTGTP, medicinal products and medical devices.
Adverse Event Online Database
You may access the HSA Adverse Event Online Database for information about suspected local adverse events of therapeutic products and medicinal products captured from reports submitted to us by healthcare professionals as well as companies.
Industry partners may access through the HSA AE Online Enquiry e-service.
Healthcare professionals may access through the Health Professionals Portal (HPP) website and follow the procedures below:
Select your profession under 'For Healthcare Professionals'.
Click on 'Useful links'.
Click on 'HSA Adverse Event Online' and log in via Singpass.
Click on 'HSA Adverse Event (AE) Database'.
