India’s Central drugs standard control organisation (CDSCO) has issued new draft guidance of clinical trials and new drug approvals that pave the way for potential electronic submissions.
The document, available here , covers the requirements for approval of trials, new drugs and details the CDSCO’s review process under Rule 122A, 122B, 122DA,122DAA,122E and Schedule-Y of the Drugs and Cosmetics Rule.
The organisation said that: “This guidance will help the industry to submit the required documents in a more realistic manner, which in turn will also help reviewer of CDSCO to review such application in systematic manner.
“It is apparent that this structured application with comprehensive and rational contents will help the CDSCO to review and take necessary actions in a better way and would also ease the preparation of electronic submissions, which may happen in the near future at CDSCO.”
For More Information please click here: CDSCO issues guidance on trial approvals with an eye on e-submissions
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