India Tightens Oversight Of CROs With Mandatory Registration

Contract research organizations in India must gear up to comply with new registration requirements coming into effect in April 2025 that aim to enhance the quality and integrity of clinical trials, as well as of any bioavailability and bioequivalence studies conducted by them.

Inspector writting on a clipboard. Man in the background with arms crossed. Inspection by supervisors in a office
A CRO May Be Inspected With Or Without Prior Consent Under New Rules • Source: Shutterstock

The Indian government has made legislative changes to introduce mandatory registration requirements for clinical research organizations, also referred to as contract research organizations in some jurisdictions, to better oversee their conduct and operations.

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