The Central Drugs Standard Control Organization has issued a Notice on 18th October 2019, specifying that Ethics Committee that applied for re-registration/ renewal of the registration and is under processing, will remain valid until new Order is passed by CDSCO.
This Notice has been issued in furtherance of Notification dated March 19, 2019 notifying the New Drugs and Clinical Trials Rules, 2019 to govern ethics committees that review and approve clinical trials and BA BE study protocols for new drugs. Under prior Drugs and Cosmetic Rules, 1945, the registration granted by CDSCO was valid only for 3 years and the re-registration shall be made within 3 months before expiry.
According to the New Rules, the Registration is valid for 5 years and the application for renewal shall be made to the central licensing Authority within 3 months prior to the date of expiry.
Therefore vide this Notice, it is specified that Ethics Committee which have submitted their application for re-registration or renewal of registration will remain valid until further Orders by CDSCO.
Click here to read the Notification
