New Initiatives for Registration of Therapeutic Products 14 May 2021

Enhanced Dossier Clarification Supplement on Chemistry, Manufacturing & Controls (CMC) for New Drug Applications and Generic Drug Applications

TPB introduced the Dossier Clarification Supplement in April 2018 for chemical NDA and GDA to facilitate applicants to leverage the approval from a reference agency for the regulatory filing to HSA through the submission of supplementary information, as well as confirmation of the CMC aspects of a therapeutic product for which regulatory approval is sought in Singapore are the same as those approved by a reference agency. Based on the experience thus far, the approach has enabled greater regulatory efficiency and minimised duplication of evaluation effort.

To further optimise the leveraging approach, TPB is extending the Dossier Clarification Supplement to NDA for biologics. In addition, Appendix 18A has been updated to allow applicants to provide confirmation that the drug substance and drug product specifications, container closure system and shelf life of the drug product proposed for Singapore are the same as approved by a reference agency. We strongly encourage that applicants provide the relevant information and confirmation in order to allow HSA to better leverage the assessment done by our reference agencies for the expeditious processing of your applications.

We are pleased to share with you the updated Appendix 18 and 18A, which will take effect from 1 June 2021.

Published: 14 May 2021

Regulatory Updates