CDSCO Moves Clinical Trial Applications for Site Addition and PI Changes Online
Key Insights
The CDSCO (search) has mandated online submission for clinical trial site addition and principal investigator (PI) changes via the Sugam portal.
This shift aims to streamline regulatory submissions for global clinical trials, new drug trials, and bioavailability/bioequivalence studies.
Approvals for site additions are deemed granted if no objection is raised within 30 days, while PI changes are effective upon application receipt, provided the application is complete.
The Central Drugs Standard Control Organisation (CDSCO (search)) has directed the pharmaceutical industry to submit applications for clinical trial site additions and changes of principal investigators (PIs) through an online portal. This move is designed to streamline the regulatory submission process and enhance efficiency.
Online Submission via Sugam Portal
According to a notice issued by Drugs Controller General (India) Dr. Rajeev Singh Raghuvanshi, applicants must now use the Sugam portal (www.cdscoonline.gov.in) for these submissions. The online application should include a checklist of required documents and ethics committee approvals. This requirement applies to global clinical trials, clinical trials of new drugs, subsequent new drugs, investigational new drugs, fixed-dose combinations, and bioavailability/bioequivalence studies.
Approval Timelines
The CDSCO (search) has outlined specific timelines for application approvals. A proposed addition of a clinical trial site is considered approved if the CDSCO raises no objections within 30 days of receiving the application. Changes to the principal investigator are deemed approved from the date the application is received, provided it is complete and adheres to the checklist requirements.
Broader Digitization Efforts
This initiative is part of CDSCO (search)'s ongoing efforts to digitize and streamline regulatory processes. Previously, the CDSCO transitioned the submission of Periodic Safety Update Reports (PSURs) for marketing authorization of new drugs to online systems. The veterinary division has also shifted the submission of Form 44 for import or manufacture permissions for new drugs to an online mode.
In November 2023, the CDSCO (search) mandated online submissions for Post Approval Changes (PACs) related to marketing authorization for human vaccines and antisera, discontinuing offline submissions from December 1, 2023. Earlier in 2023, the procedure for submitting test licenses for veterinary vaccines and drugs was also moved online. In 2021, applications for registration of bioequivalence study centers and PACs in bioequivalence studies were digitized.
National Single Window System
On January 1, 2024, the CDSCO (search) launched the National Single Window System (NSWS) portal, initially offering three activities for the medical devices industry. This system aims to improve the ease of doing business within the industry by providing a centralized platform for regulatory submissions and approvals.