CDSCO Launches Online Portal for Clinical Trial Site Additions and PI Change Applications
Thursday, 27 February 2025, 12:28 IST
The Central Drugs Standard Control Organization (CDSCO) has expanded its online submission system to include applications for clinical trial site additions and Principal Investigator (PI) changes for biological products. This move follows a similar decision made in December 2024, where the CDSCO began accepting online applications for clinical trial site additions and PI changes across various clinical trials, including global studies, new drugs, investigational new drugs, fixed-dose combinations, and bioavailability & bioequivalence studies. The shift to digital submissions is part of the CDSCO's ongoing efforts to streamline and modernize the regulatory process, improving efficiency for researchers and drug developers.
Now, it has announced that the option is also functional for clinical trials of Biological products such as vaccines and rDNA.
"Applicants seeking for approval of Clinical Trial Site Addition and change of Principal Investigator applications for all the clinical trials may apply through the online portal", says Dr Rajeev Singh Raghuvanshi, Drugs Controller General (India), in a notice issued to all stakeholders. The proposed addition or change will be deemed to be approved if no objection is raised by the CDSCO within a stipulated time frame.
Applicants must submit their clinical trial site addition and Principal Investigator (PI) change applications through the Sugam Portal, accompanied by a checklist of required documents and approval from the ethics committee. The CDSCO will consider the proposed addition of clinical trial sites approved if no objections are raised within 30 days of receiving the application. Similarly, changes to the Principal Investigator will be deemed approved from the date of application receipt, provided the submission is complete as per the checklist.
This move is part of CDSCO's ongoing efforts to digitize and streamline the regulatory process. Previously, the CDSCO transitioned several applications, including Periodic Safety Update Reports (PSURs) for new drug marketing authorizations, to online systems. Additionally, the veterinary division has announced the transition of Form 44 submissions for new drug import or manufacturing permits from offline to online.
In November 2023, the CDSCO instructed all stakeholders to submit Post Approval Changes (PACs) for marketing authorization of human vaccines and antisera through the Sugam Portal, marking the end of offline submission processes starting December 1, 2023. Earlier in 2023, the CDSCO transitioned the submission of test license forms for veterinary vaccines and drugs to an online system, eliminating offline submissions in hard copy.
In 2021, the regulator also moved applications for registration of centers for bioavailability and bioequivalence (BA/BE) studies, along with PAC applications for BA/BE studies, to an online platform. As part of its ongoing digitization efforts, the CDSCO launched the National Single Window System (NSWS) portal on January 1, 2024. Initially offering three services for themedical devices industry, the NSWS aims to enhance the ease of doing business in the sector.
Now, it has announced that the option is also functional for clinical trials of Biological products such as vaccines and rDNA.
"Applicants seeking for approval of Clinical Trial Site Addition and change of Principal Investigator applications for all the clinical trials may apply through the online portal", says Dr Rajeev Singh Raghuvanshi, Drugs Controller General (India), in a notice issued to all stakeholders. The proposed addition or change will be deemed to be approved if no objection is raised by the CDSCO within a stipulated time frame.
Applicants must submit their clinical trial site addition and Principal Investigator (PI) change applications through the Sugam Portal, accompanied by a checklist of required documents and approval from the ethics committee. The CDSCO will consider the proposed addition of clinical trial sites approved if no objections are raised within 30 days of receiving the application. Similarly, changes to the Principal Investigator will be deemed approved from the date of application receipt, provided the submission is complete as per the checklist.
This move is part of CDSCO's ongoing efforts to digitize and streamline the regulatory process. Previously, the CDSCO transitioned several applications, including Periodic Safety Update Reports (PSURs) for new drug marketing authorizations, to online systems. Additionally, the veterinary division has announced the transition of Form 44 submissions for new drug import or manufacturing permits from offline to online.
In November 2023, the CDSCO instructed all stakeholders to submit Post Approval Changes (PACs) for marketing authorization of human vaccines and antisera through the Sugam Portal, marking the end of offline submission processes starting December 1, 2023. Earlier in 2023, the CDSCO transitioned the submission of test license forms for veterinary vaccines and drugs to an online system, eliminating offline submissions in hard copy.
In 2021, the regulator also moved applications for registration of centers for bioavailability and bioequivalence (BA/BE) studies, along with PAC applications for BA/BE studies, to an online platform. As part of its ongoing digitization efforts, the CDSCO launched the National Single Window System (NSWS) portal on January 1, 2024. Initially offering three services for themedical devices industry, the NSWS aims to enhance the ease of doing business in the sector.
