Process of post approval changes in Clinical Trial

It has been decided that cases of post approval changes will be processed by CDSCO within 15 working days of receipt of application

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It has been decided that cases of post approval changes will be processed by CDSCO within 15 working days of receipt of application for approval or acknowledgment or otherwise, as per a Drugs Controller General of India (DCGI) notice.

Post approval changes includes changes in protocols, study site and principal Investigator, among others.

Permission to conduct Bio-availability/Bio-equivalence (BA/BE) study of new drug for export purpose is granted by Central Licensing Authority (CLA) as per the New Drugs and Clinical Trials Rules, 2019 in Form CT-07.

Import license in Form CT-17 is also granted for import of study drug for this purpose.

The conditions of permission for conduct of BA/BE study are prescribed under Rules 35 of the said Rules.

Detailed requirements and guidelines in this regard are also prescribed under Fourth Schedule of the said Rules.

Also read: CDSCO strengthens oversight of Clinical Trials

New Drug and Clinical Trial Rules, 2019 effective from September 21, 2019 has also stipulated timelines for review and approval of CT applications as 30 days for Investigational New Drugs (INDs) being developed in India.

If no response from DCGI, automatic approval is given by DCGI via Form CT-4 A.

CDSCO last year in October had urged drug manufacturers to submit stability studies data as per New Drugs and Clinical Trials Rules, 2019.

Concerns were raised at various forums with respect to the requirement of stability study to be submitted along with application for grant of permission to conduct clinical trial and BA/BE studies.

As per New Drugs and Clinical Trials Rules, 2019, clinical trial in relation to a new drug or investigational new drug means any systematic study of such new drug or investigational new drug in human subjects meant to generate data for discovering or verifying its clinical or pharmacological including pharmacodynamics, pharmacokinetics or adverse effects with the objective of determining the safety, efficacy or tolerance of such new drug or investigational new drug.

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