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Class 2 CTGTP Registration

Find out how to register your Class 2 cell, tissue or gene therapy product (CTGTP) and retain, cancel or transfer a product registration here.

Registration overview Understand the cell, tissue or gene therapy product registration process before you register your product. GMP conformity assessment of overseas manufacturers Overseas manufacturers who intend to register CTGTP in Singapore may be subjected to a Good Manufacturing Practice (GMP) conformity assessment by HSA. RMP submission for product registration Find out when a risk management plan (RMP) submission is required and the documents to be submitted. Special Access Routes (SAR) In specific situations, we may allow the import or the supply of Class 2 cell, tissue or gene therapy products (CTGTP) via Special Access Routes (SAR).

Last updated: 31 Dec 2018