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Regulatory News
1 December 2014
by Louise Zornoza

Indian Regulators Call for Comment on Revised Clinical Trial Standards

This content is provided by RegLink News, publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members.

India’s Central Drugs Standard Control Organization (CDSCO), the country's medicines regulator, is seeking input from the public on draft revised accreditation standards for clinical trials.

The standards were prepared by the National Accreditation Board for Hospitals and Healthcare Providers (NABH) and the Quality Council of India, in consultation with various stakeholders.

The draft sets out the criteria for the accreditation of ethics committees, investigators and the sites where clinical trials are to be carried out.

The deadline for comments is December 15, 2014.

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