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 2025

Agency	Guidance Title	Date
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
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
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