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Health Sciences Authority

Post-registration RMP obligations

Understand your RMP obligations as registrants of therapeutic products and CTGTP.

Last updated 17 March 2026

Implementation of RMP requirements

Registrants are responsible for the implementation and continued compliance with the RMP requirements to characterise or minimise the risks associated with their products. These include routine PV activities and RMA, as well as additional PV activities and RMA stipulated in the product registration conditions. Other information, such as clinical safety study reports and data on local product utilisation, may also be requested by HSA on an ad hoc basis.

Safety notification to HSA

Find out when submission of a safety notification is required for registered therapeutic products and CTGTP.

Submission of PBRER upon HSA's request

Understand the requirements related to the submission of periodic benefit-risk evaluation reports.

HSA-approved educational materials

Understand the requirements related to distribution, revision and discontinuation of HSA-approved educational materials.

HSA-approved controlled access programme or pregnancy prevention programme

Find out what information may be requested for HSA-approved controlled access programme or pregnancy prevention programme.