Singapore HSA updated Guidance for Post-marketing Vigilance Requirements for Therapeutic Products and Cell, Tissue and Gene Therapy Products (CTGTP), effective 1 April 2026.
Apart from editorial changes made, the following areas are updated to provide better clarity to the guidance:
– Provided additional details on point of contact requirements
– Updated criteria for submission of serious adverse events, with distinction between spontaneous and solicited reports
– Added examples to define identifiable patient
– Updated types of adverse events which are not subject to reporting requirements
– Updated criteria for submission of adverse events arising from literature
– Updated criteria for submission of lack of efficacy reports
For detailed changes made to the relevant sections or information in the guidance, please refer to the summary of changes listed in the latest guidance here: https://www.hsa.gov.sg/docs/default-source/hprg-vcb/guidance-document/guidance-for-industry_post-marketing-vigilance-requirements-for-therapeutic-products-and-ctgtp_v6_01-apr-2026.pdf?sfvrsn=1d96a56c_3