On 14 May 2021, the Health Sciences Authority (HSA) Therapeutic Products Branch announced that it would be extending the Dossier Clarification Supplement to new drug applications (NDA) for biologics. The extension takes effect from 1 June 2021.
Stakeholders interested in using the Dossier Clarification Supplement to expedite registration of NDAs for biologics should note that the drug substance, product specifications, container closure system, and shelf life of the drug product for Singapore must be the same as those approved by a reference agency.
In more detail
The changes, reflected in the updated Appendix 18 and 18a, may be found here.
The Dossier Clarification Supplement was first launched in April 2018 for chemical NDA and generic drug applications (GDA). This was introduced to expedite the regulatory review process and allow applicants to leverage on approvals from reference agencies.
The full HSA regulatory update may be found here.