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CDSCO (India)
REGULATION
2026.09.03 G.S.R. 790(E)_Draft Notification for extension of prior intimation system for certain BA and BE studies for approval of New Drugs in India
Published: 9/3/2026Detected: 9/17/2026

Summary preview

Extends the use of a prior intimation mechanism for specified bioavailability (BA) and bioequivalence (BE) studies submitted to CDSCO as part of approval of new drugs in India.

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