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In brief

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.

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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.


Andy Leck is the managing principal of Baker McKenzie.Wong & Leow. Mr. Leck is recognised by the world’s leading industry and legal publications as a leader in his field. Asian Legal Business notes that he “always gives good, quick advice, [is] client-focused and has strong technical knowledge for his areas of practice”. Alongside his current role as managing principal, Mr. Leck has held several leadership positions in the Firm and externally as a leading IP practitioner. He currently serves on the International Trademark Association's Board of Directors and is a member of the Singapore Copyright Tribunal.


Ren Jun is an associate principal of Baker & McKenzie.Wong & Leow. Ren Jun extensively represents local and international intellectual property-intensive clients in both contentious and non-contentious IP matters, such as anti-counterfeiting; civil and criminal litigation; commercial issues; regulatory clearance; and advertising laws. Ren Jun also advises on a wide range of issues relating to the healthcare industries. These include regulatory compliance in respect of drugs, medical devices, clinical trials, health supplements and cosmetics; product liability and recall; and anti-corruption. Ren Jun is currently a member of the Firm's Asia Pacific Healthcare ASEAN Economic Community; Product Liability and Regulatory Sub-Committees.

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