Health Sciences Authority (HSA) has updated the Guidance on Cell, Tissue or Gene Therapy Product (CTGTP) Registration and Variation Applications in Singapore, as well as the related Minor Variation (MIV) Checklist for Class 2 CTGTP.
The amendments made to the main guidance are summarized as following:
– MIV-2 applications were reclassified into two categories: MIV-2 (Notification) and MIV-2 (Do-and-Tell) under section 5.1.1.
– Information on requirements of MAV-1 was updated under Sections 5.2.1.
– Added statement “At any one time, you may submit up to three concurrent MAV-1 applications for each registered CTGTP.” to section 5.2.3.
– Definitions of MIV-1/MIV-2 applications and submission options for MIV-2 (Do-and-Tell) were updated under Section 5.3.1.
– Requirement for Do-and-Tell changes to be submitted within 6 months of date of implementation was added under Section 5.3.2.
– Added statement “For documents which are not in English, a certified translation is acceptable” to sections 2.1, 5.2.3 and 5.3.3.
– Sentences regarding dossier format, language requirements, and HSA’s authority to request withdrawal/resubmission were relocated to relevant sections for clarity.
– Fax number on the back cover page was removed as it is no longer in use.
To view the latest guidance and MIV checklist, please visit HSA’s webpage at the following link: https://www.hsa.gov.sg/ctgtp/guidance-documents