PHARMAEDGES REGULATORY REFERENCE GUIDES
Read selected regulatory developments and follow official sources. Explore FDA, EMA, CDSCO, ICH, WHO and PIC/S reference guides below.
NEWS & UPDATES
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Selected developments, newest first. Publication dates and document status are shown for each item. This is an editorial selection, not an automated or exhaustive feed.
The ACT EU advice pilot will become a permanent initiative in January 2027, continuing technical and regulatory support for sponsors preparing applications through CTIS.
Announced on 8 October; the permanent initiative starts in January 2027. This is pre-submission support, not a clinical-trial authorisation.
Read summary and practical context →Read official sourceEMA advises submission by 20 November for specified type IA submissions seeking a 2026 outcome, and by 30 November for type IB submissions seeking a 2026 procedure start.
Planning dates are tentative and depend on submission volume and complexity. Later submissions may receive an outcome or procedure start in January 2027.
Read summary and practical context →Read official sourceThe report covers 2017–2024 and describes how information sharing helps coordinate GMP oversight and reduce duplicate inspections. The programme grew from 10 to 13 participating authorities.
Source report updated 21 September 2026. This is a programme report, not a new GMP requirement.
Read summary and practical context →Read official sourceCDSCO lists G.S.R. 791(E), a proposed amendment to the Drugs Rules, 1945 concerning mandatory CCTV installation at sales premises.
Proposal only. Check the Gazette entry and subsequent notifications before treating this as an operative requirement.
Read summary and practical context →Read official sourceG.S.R. 790(E) proposes extending the prior-intimation system for certain bioavailability and bioequivalence studies supporting new-drug approval in India.
Proposal only. The official Gazette listing identifies the document; read it for eligible studies and conditions.
Read summary and practical context →Read official sourceREFERENCE GUIDES
Choose an authority or quality topic to find an official starting point and practical reading prompts. The guides below provide background to the dated updates above.
Find FDA drug-quality resources and routes to CGMP guidance.
Find EMA GMP information, EU guideline links and inspection resources.
Find Indian drug-regulatory notices, rules and guidance through the CDSCO portal.
Find the ICH quality-guideline directory for pharmaceutical quality topics.
Find WHO GMP reference documents and associated technical-report material.
Find PIC/S guides and publications relevant to GMP and inspection preparation.
HOW TO USE THE DIRECTORY
Start with the organisation or topic relevant to your work. Source pages may contain multiple document versions; read the full document before applying it. PharmaEdges reading prompts are explanatory summaries.
Follow the official link to locate the document relevant to your product, activity and market.
Distinguish draft from final material. A publication date is not necessarily an effective or implementation date; read those dates in the source.
Record the source version and assess implications through your approved change-control or quality process.
USING THESE REFERENCES
Find the relevant source and understand the scope of these guides.
Dated, source-linked regulatory updates followed by a directory of official regulatory and standards resources.
Read the news cards above for selected developments and their source dates. Follow each official link for full scope and current status; this selection is not exhaustive.
This directory includes both regulatory authorities and organisations that publish harmonised guidelines or quality standards. Confirm implementation in the relevant jurisdiction.