On 1st April 2024, Singapore HSA updated Guidance for Post-Marketing Vigilance Requirements for Therapeutic Products & Cell, Tissue and Gene Therapy Products. The updates mainly involved the following aspects:
- Risk Management Plans (RMP)
- Routine PV activities and Risk Minimisation Activities (RMA) should be conducted for all products registered in Singapore, regardless of RMP submission to HSA.
- Requirement of RMP submission for biosimilar products registration is removed.
- Core RMP is included as example of reference RMP that can be submitted to HSA.
- Format of Singapore Specific Annex (for RMP submission) is changed to an online PDF interactive form
- Submission method of an updated RMP during application review is added.
- More information is added for the requirement records for controlled access programs or pregnancy prevention programs.
- Safety Notification to HSA
- Update to warnings or safety information in the oversea product labelling requested by HSA’ comparable overseas regulators (Australia TGA, EMA, Health Canada, UK MHRA, US FDA) are required to notify HSA.
- Ongoing assessments for potential safety signals with no interim measures planned by the registrant or HSA’s comparable overseas regulators do not need be notified to HSA.
- Submission of Periodic Benefit-Risk Evaluation Report (PBRER)
- Clarification to the requirements
To view the updated guidance, please visit the following link: https://www.hsa.gov.sg/docs/default-source/hprg-vcb/guidance-document/guidance-for-industry_post-marketing-vigilance-requirements-for-therapeutic-products-and-ctgtp__v4_01apr2024.pdf?sfvrsn=bea59b8e_2