With a view to align the submission procedure of clinical trial application (as prescribed under the New Drugs and Clinical Trial Rules, 2019) and the SUGAM application process, the Central Drugs Standard Control Organization (“CDSCO”) has issued a draft guidance document for the industry (Version 1.2) (“Draft Guidance Document”). This document aims to streamline and enhance the efficiency of the clinical trial application submission process.
Central Drugs Standard Control Organization (“CDSCO”) has invited public comments on the Draft Guidance Document till 25th April, 2024. Submission of the comments / suggestions / objections can be made through an e-mail at vaccine-bio@cdsco.in.
The draft guidance document broadly covers the processes / requirements / information regarding:
• Submission of Clinical Trial Application for Evaluating Safety and Efficacy
• Requirements for Permission of New Drugs Approval
• Preparation of the Quality Information for Drug Submission for New Drug Approval: Biotechnological / Biological Products
Source: Central Drugs Standard Control Organization
