New Delhi, Sept. 3 -- The union Health Ministry today said that it is in the process of amending the New Drugs and Clinical Trials (NDCT) Rules, 2019, aiming to streamline regulatory procedures and reduce approval timelines for clinical trials and new drug manufacturing.
In this regard, it has issued a draft notification proposing significant amendments to the New Drugs and Clinical Trials Rules (NDCTR), 2019.
The draft has proposed to reduce the approval timelines for clinical trials and related permissions from ninety working days to forty-five working days to accelerate the regulatory review process.
The amendments aim to simplify the requirements and procedures for obtaining test licences and for submitting applications related to Bi...