Circular on Implementation of Prior intimation System for Form CT-05 application (for export purpose only) w.e.f 21.04.2026 in pursuance of G.S.R 50(E) dated 21.01.2026

This circular, issued by CDSCO on 20 April 2026, announces the implementation of the Prior Intimation System for Form CT-05 applications, applicable exclusively for export purposes, effective from 21 April 2026. The system follows amendments introduced through Gazette Notification G.S.R. 50(E) dated 21 January 2026 under the New Drugs and Clinical Trials Rules, 2019. Stakeholders must submit online applications via the Sugam portal, where the acknowledgment itself will serve as prior intimation. The circular specifies conditions for bioavailability/bioequivalence studies, including oral dosage forms (excluding cytotoxic, hormone, narcotic, psychotropic, narrow therapeutic index, or highly variable drugs), approval status in India or SRA Countries, ethics committee approval, and a minimum sample size of eighteen. Ethics Committees are required to maintain separate records of such studies for review during inspections or renewals. For categories not covered, the existing prior approval system remains applicable.