Regulation/Guidelines

CDSCO has made it mandatory for Ethics Committee to get registered so as to get authority to review and accord its approval to Clinical Trial protocol

  • 28th July, 2012

Under rule 122 DD Registration of Ethics committee (EC) – No ethics committee shall review and accord its approval to a clinical trial protocol without prior registration of the committee with the licensing authority as defined in clause (b) of rule 21. An application for registration of Ethics Committee shall be made to the licensing authority in accordance with the requirements prescribed in schedule Y-1.