Relaxing Norms for Toxicity Studies in Drug Approval
The CDSCO aims to streamline the drug approval process without compromising safety. The New Drugs and Clinical Trials Rules, 2019 allow for the acceptance of preclinical toxicity data generated in other countries, provided the data is of high quality and meets specified standards.
Applications for PAC in Vaccine Clinical Trials Now Online
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. With the introduction of the online system of SUGAM portal, the CDSCO seeks to streamline the regulatory submission procedure.
