CDSCO · Draft notification
India proposes extending prior intimation for certain BA/BE studies
Official source date: · Source checked
G.S.R. 790(E) proposes extending the prior-intimation system for certain bioavailability and bioequivalence studies supporting new-drug approval in India.
Who should review this?
Regulatory affairs teams, study sponsors and organisations planning BA/BE studies for India.
What it means for pharmaceutical teams
Bioavailability and bioequivalence studies support particular regulatory questions. A proposal for a prior-intimation pathway does not establish that every study is eligible or remove other requirements.
Practical review checklist
PharmaEdges reading prompts for your own applicability review:
- Find G.S.R. 790(E) in the official Gazette listing.
- Compare the proposed eligible study categories with the planned study.
- Confirm the current approval pathway and subsequent notifications before changing a submission plan.
Official source and verification
Read the CDSCO source (opens in a new tab)
This article summarises the linked official material. The context and checklist are PharmaEdges explanatory commentary, not additional regulatory requirements. The source publication date is separate from this article’s publication date.
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