Draft Guidance Document On Submission of Clinical Trial Applications

The Central Drugs Standard Control Organization (CDSCO) has invited suggestions and comments from stakeholders on the draft revision of its Guidance for Industry on Submission of Clinical Trial Application for Evaluating Safety and Efficacy. This notice was dated April 10, 2024.

The draft Guidance for Industry, Version 1.2, aims to align with the New Drugs and Clinical Trials Rules, 2019. It also seeks to incorporate the SUGAM application process for drug approvals. The CDSCO seeks feedback to ensure the revised guidance effectively supports the industry.

Stakeholders can submit their suggestions, comments, or objections electronically by April 25, 2024. This feedback may be sent to the email address, vaccine-bio@cdsco.nic.in

CDSCO aims to finalize a the guidance document that promotes quality information on drug submitted for new drug approval in biotechnological/ biological products. It also aims to strengthens clinical research methodologies, and fosters transparency within the sector.