The Central Drugs Standard Control Organisation (CDSCO) has issued a circular on the launch of the online system Post Approval Changes (PAC) with respect to the clinical trials of vaccines and associated approvals. A circular on this launch was issued on 26th October, 2023.
With the introduction of the online system of SUGAM portal, the CDSCO seeks to streamline the regulatory submission procedure. The system will cater to the following kinds of submssions:
- PAC for clinical trials of vaccines in form CT-06
- Approval for protocol
- Approval for report of Post Marketing Surveillance (PMS) study for human vaccines and anti-sera
All applicants must apply through the online portal as per the checklist provided in the module.
It is important to note that the facility for offline submission of applications in hard copy will not be available from 1st November, 2023.
