Indian Regulators Ready Online Clinical Trial Submission System
India’s Central Drugs Standard Control Organization (CDSCO) has issued an official order facilitating online submissions of clinical trial applications in the country.
The online submission system for clinical trial application submissions is the first step toward CDSCO’s plans to launch a wider system encompassing both trial application processing and monitoring of all trials for drugs and medical devices conducted in India.
For now, applicants can upload their submission materials only in order to receive regulatory feedback; until the online system is fully implemented, CDSCO will continue to accept hard copies of clinical trial applications. No further timeframes for further implementation of the system have been provided yet.
(As of this post’s publication, the CDSCO’s clinical trial online submission site is offline.)