New Regulatory Updates

We list here guidelines pharmaceutical manufacturing issued by regulatory agencies worldwide.. You can read full guidance document by clicking on the title.
Guidance Documents 2026
Agency Guidance Title Date
FDA Bioanalytical Method Validation for Biomarkers 10/04/2026
CDSCO Manufacturing and marketing of unapproved drug product Sodium Hyaluronate Eye Drops 0.3% w/v 18/03/2026
FDA Pyrogen and Endotoxins Testing: Questions and Answers: Guidance for Industry 18/03/2026
CDSCO Guidance document on dossier based licensing of Drugs for uniform product licensing in the country 17/03/2026
CDSCO Advisory to all manufacturers, importers and marketing authorization holders 11/03/2026
CDSCO Testing Laboratories approved by Statas&UT in Form 37 of Drugs Rule 1945 and Cos 23 of Cosmetics Rule 2020 10/03/2026
ICH E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports 03/03/2026
ICH M14 General Principles on Planning, Designing, Analyzing, and Reporting of Non-interventional Studies That Utilize Real-World Data for Safety Assessment of Medicines 03/03/2026
CDSCO Doxycycline related CNS Side Effects (Restlessness, Anxiety, Irritability, Nervousness, and Dizziness) - Recommendations for the change in Prescribing Information Leaflets (PILs) 17/02/2026
CDSCO Risk classification list of medical devices pertaining to Oncology 02/01/2026


Guidance Documents 2025
Agency Guidance Title Date
WHO Bioequivalence for Immediate Release Oral Dosage Form (QAS25.990) 25/12/2025
FDA Processes and Practices Applicable to Bioresearch Monitoring Inspections: Guidance for Industry 19/12/2025
FDA ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs: Guidance for Industry 16/12/2025
FDA Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices: Guidance for Industry 15/12/2025
CDSCO New provision for Risk Classification of Medical Devices 05/12/2025
FDA Medical Gases — Current Good Manufacturing Practice: Draft Guidance for Industry 28/11/2025
EU EudraLex Volume 10: Clinical trials guidelines 30/10/2025
CDSCO Strict compliance with the Drugs Rules 1945 for testing of raw materials and finished formulations 07-10-2025
CDSCO Separate provision for subsequent Importer in Online system for Medical Devices 15-09-2025
FDA Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications 11-09-2025
ICH E6(R3) Good Clinical Practice (GCP) 09-09-2025
WHO Draft revision of chapter 2.11: Micro determination of water by the Karl Fischer Method (QAS/25.986) 28-07-2025
CDSCO Issues related to safety of Ranitidine drug due to presence of NDMA impurity 24-07-2025
WHO 1.18 High-performance thin-layer chromatography 15-07-2025
WHO Determination of diethylene glycol and ethylene glycol in liquid preparations for oral use 15-07-2025
FDA ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions 13-06-2025
CDSCO Guidance document on disposal of expired/ unused drugs 27-05-2025
WHO Procedure for prequalification of pharmaceutical products (QAS/25.974) 01-03-2025
WHO WHO General guidelines for the establishment, maintenance and distribution of chemical reference substances (QAS/25.972) 25-02-2025
CDSCO Guidance document Validation of Rapid Diagnostics for Pathogen Identification and Antimicrobial Susceptibility Testing (AST) 16-01-2025
FDA Considerations for Complying with 21 CFR 211.110 06-01-2025
WHO WHO Points to consider in continuous manufacturing of pharmaceutical products (QAS/24.957) 05-01-2025


Guidance Documents 2024
Agency Guidance Title Date
FDA Advanced Manufacturing Technologies Designation Program 31-12-2024
ICH E11A Pediatric Extrapolation 30-12-2024
ICH M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms 30-10-2024
CDSCO Draft Guidelines on Good Clinical Practices 12-09-2024
FDA Control of Nitrosamine Impurities in Human Drugs 05-09-2024
CDSCO Draft CDSCO Guidance for Industry: Post Approval Changes in Biological Products 28-02-2024