Pharma & Drug Safety

ICH Guidelines Overview

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) provides guidelines across quality, safety, efficacy, and multidisciplinary areas. These guidelines aim to harmonize technical requirements for pharmaceutical registration globally.

ICH Q1A(R2) Stability Testing Guideline Finalized

The International Council for Harmonisation (ICH) has finalized its Q1A(R2) guideline on stability testing of new drug substances and products. This revised guideline, effective February 6, 2003, provides updated recommendations for stability testing protocols across different climatic zones.

European Pharmacopoeia Launches All-Digital 12th Edition

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has launched the all-digital 12th Edition of the European Pharmacopoeia (Ph. Eur.). This new edition is available on a redesigned platform with a 365-day licence, marking a significant shift in how users access official quality standards for medicines in Europe.

Newsletter Transplant 2025: Organ Donation and Transplantation Data

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published the 'Newsletter Transplant 2025', detailing global organ donation and transplantation activities in 2024. The report indicates a 2% increase in global transplants, with 44,021 procedures performed in Council of Europe member states.

European Donation Day 2025 Promotes Organ, Tissue, and Cell Donation

The European Directorate for the Quality of Medicines & HealthCare (EDQM) announced European Donation Day 2025, scheduled for October 11, 2025. This initiative aims to promote organ, tissue, and cell donation and honor donors, their families, and healthcare professionals. Greece will host the event, with related meetings and awareness campaigns.

EDQM Publishes 22nd Edition of the Blood Guide

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published the 22nd edition of its Blood Guide. This updated guide includes revisions to haemovigilance, new chapters on topical blood components and emergency planning, and updated donor selection criteria.

PIC/S GMP Annex Revisions and Membership Applications

The EMA and PIC/S have released concept papers for revisions to GMP Annex 15 (Qualification and validation) and Annex 6 (Manufacture of medicinal gases). These documents are open for public consultation until April 2026. Additionally, Kazakhstan has applied for PIC/S membership.

PIC/S EU GMP Guides: Consultation on Documentation, AI, and Computerised Systems

PIC/S and the European Commission have launched a joint stakeholder consultation on revisions to the EU GMP Guides, specifically Chapter 4 (Documentation) and Annex 11 (Computerised Systems), and a new Annex 22 on Artificial Intelligence. The consultation period runs from July 7, 2025, to October 7, 2025.

PIC/S EU GMP Guide Revision of Chapter 1 on Pharmaceutical Quality System

The European Commission and PIC/S are jointly consulting on a revision to Chapter 1 of the EU GMP Guide concerning Pharmaceutical Quality Systems. The update aligns with ICH Q9(R1) on Quality Risk Management and aims to enhance regulatory frameworks, ensure medicine quality, and mitigate supply chain risks.

EU-PIC/S GMP Annex 3 Revision Concept Paper Released

The EMA and PIC/S have released a concept paper proposing revisions to Annex 3 of the EU-PIC/S GMP Guide concerning the manufacture of radiopharmaceuticals. This consultation period runs until February 15, 2026, and aims to update guidance to reflect current practices and innovative approaches.