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Health Sciences Authority

Post-market surveillance, safety monitoring and advertisement

Find out the requirements related to post-market surveillance, safety monitoring and advertisement.

Last updated 23 March 2026

Adverse event reporting of cell, tissue or gene therapy products (CTGTP)

CTGTP importers, manufacturers, suppliers and registrants are required to report all serious adverse events of their products.

Advertisements and promotions of CTGTP

Advertisers are responsible in ensuring compliance with legislation and guidelines before advertising and promoting cell, tissue and gene therapy products (CTGTP) in Singapore.

Product defect reporting and recall procedures for cell, tissue or gene therapy products (CTGTP)

Find out when and how to report or recall defective CTGTP that may potentially cause harm to patients or public health.

Product registrants are also responsible for the implementation and continued compliance with the risk management plan (RMP) requirements for their products. Find out more at Post-registration RMP obligations.