**Summary:**
This notice from the Central Drugs Standard Control Organization (CDSCO), dated December 26, 2024, announces the implementation of an online submission process via the SUGAM portal (www.cdscoonline.gov.in) for applications related to Clinical Trial Site Addition and change of Principal Investigator. This applies to Global Clinical Trials, Clinical trials of New Drugs, Subsequent New Drugs, Investigational New Drugs, Fixed Dose Combinations, and Bioavailability/Bioequivalence studies. Applicants must submit applications through the SUGAM portal, including a checklist of required documents and Ethics Committee approval. The addition of clinical trial sites will be considered approved if no objection is received from the CDSCO within 30 days of application receipt. A change of Principal Investigator is deemed approved from the date of receipt, contingent upon the application being complete according to the provided checklist. This notice is disseminated to all stakeholders via the CDSCO website and the CDAC Team. The reference number for this notice is F.No.10171DCGI102024eoffice. The CDSCO is located at FDA Bhawan, Kotla Road, New Delhi-110002.
Key Entities Referenced
Central Drugs Standard Control Organization: The national regulatory body for pharmaceuticals and medical devices in India, responsible for approving clinical trials.
SUGAM Portal: An online portal (www.cdscoonline.gov.in) used for regulatory submissions to the CDSCO, including applications for clinical trial site additions and principal investigator changes.
Clinical Trial Site Addition: The process of adding a new location where a clinical trial is conducted, requiring regulatory approval.
Principal Investigator: The lead researcher responsible for the conduct of a clinical trial at a specific site, and changes require regulatory approval.
Global Clinical Trials: Clinical trials conducted across multiple countries, subject to CDSCO regulations when conducted in India.
New Drugs: Pharmaceutical products that have not been previously approved for marketing in India, requiring clinical trials and regulatory approval.
Ethics Committee: A committee responsible for reviewing and approving research proposals involving human subjects, ensuring ethical considerations are met.
New Delhi, Delhi: Location of the Central Drugs Standard Control Organization (CDSCO) headquarters.
F.No.10171/DCGI/10/2024-eoffice
Government of India
Directorate General of Health Service
Central Drugs Standard Control Organization
FDA Bhawan, Kotla Road,
New Delhi-110002
wun 26 DEC 2024
NOTICE
Sub: Submission of Clinical Trial Site Addition and change of Principal Investigator
applications through SUGAM Portal-Reg.
In order to streamline the regulatory submission procedure, the submission of
applications for addition of Clinical Trial Site and change of Principal Investigator
are functional on online system of SUGAM Portal (www.cdscoonline.gov.in) for
Global Clinical Trials, Clinical trials of New Drugs, Subsequent New Drugs,
Investigational New Drugs, Fixed Dose Combinations and Bioavailability &
Bioequivalence studies. Applicants seeking for approval of Clinical Trial Site
Addition and change of Principal Investigator applications may apply through the
online portal.
The applicant should submit application through SUGAM along with the checklist of
documents along with the approval of the ethics committee. The proposed addition
of the clinical trial sites is deemed to be approved if no objection is received from
the CDSCO within 30days of the receipt of the application and the proposed
change of Principal Investigator is deemed to be approved by the CDSCO from the
date of receipt of application subject to the condition that application is complete as
per the checklist.
To,
1.All stakeholders through CDSCO website
2.CDAC Team