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17 Jan 2017 The regulatory framework and guidelines that govern clinical research . CDSCO office has also issued GCPs inspection checklist recently in
GUIDELINES ON APPROVAL OF CLINICAL TRIAL & NEW DRUGS. Effective Date: .. Licensing Authority based on NOC obtained from CDSCO. Test batches
8 Mar 2016 This Guideline has been developed by the appropriate ICH Expert Working Group and on 1 May 1996, this guideline is recommended for.
20 Jan 2017 2. Guidance on Clinical Trial Inspection ( 26 Jul 2012 ). CT Inspection System of Pre-screening for submission of reports of SAEs to CDSCO.
An Expert Committee set up by Central Drugs Standard Control Organisation (CDSCO) in consultation with clinical expert has formulated this GCP guideline for
The Drugs Controller General of India (DCGI)'s review and approval process .. As per the IN-GCPs, the ICMR Guidelines, and Schedule Y, the EC review

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February 2018