“On 7th Oct 2024, Singapore HSA updated Guidance for Post-Marketing Vigilance Requirements for Therapeutic Products & Cell, Tissue and Gene Therapy Products. The changes are summarised as below:
– Removed fax number from company’s contact details
– Updated submission processes for new safety information, updated reference RMP and RMP documents
– Added new requirement on the provision of the 5-year submission schedule for PBRER
– Added required text for finalised artwork of all HSA-approved educational materials
– Updated submission processes for post-registration RMP obligations
For detail of changes, please view the updated guidance at 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_v5_07-oct-2024.pdf?sfvrsn=48deb30c_4”