CDSCO specifies time limit for processing of applications under Forms CT-07, CT-11, CT-14, CT-15, CT-17 under New Drugs and Clinical Trial Rules, 2019

The Central Drugs Standard Control Organisation (“CDSCO”) has issued the following Notifications to give information regarding processing of certain applications under the New Drugs and Clinical Trial Rules, 2019 (“Rules”):

Notification dated 20th February 2020:

This Notification states that the applications for grant of permission in CT-11 / CT-14 / CT-15 / CT-17 for manufacturing or import of new drugs for test and analysis, clinical trial or BA / BE study, shall be processed by CDSCO within 7 working days of receipt of the applications.

Notification dated 21st February 2020:

This Notification states that the applications for permission to conduct BA / BE study of New Drugs for export purpose in Form CT- 07 and for Import Licence for import of study drug in Form CT-17, shall be processed by CDSCO within 15 working days of the receipt of application.

Source : Central Drugs Standard Control Organisation

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