Pharma & Life Sciences

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.

MedPAC Recommends Medicare Physician Payment Increase

The Medicare Payment Advisory Commission (MedPAC) recommended that Congress increase Medicare physician payments by an additional 0.5 percent for 2027. The American Medical Association (AMA) welcomed the recommendation, highlighting the need for stable payments to protect patient access to care.

Physician AI Use Doubles, Confidence Grows Amid Skill Loss Concerns

The American Medical Association's latest survey reveals that 81% of physicians now use AI in their practices, a significant increase from 38% in 2023. While confidence in AI's clinical benefits grows, concerns persist regarding potential skill loss and patient interpretation of results without physician oversight.

AMA Survey on Trust in Health Information

A recent survey highlights that Americans continue to trust physicians and medical organizations, like the AMA, for health information, despite declining confidence in federal health agencies. The AMA emphasizes its commitment to providing accurate, evidence-based guidance to patients.

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.

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.

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 Guide Revisions and Membership Updates

The EMA and PIC/S have released concept papers for public consultation on revisions to EU-PIC/S GMP Annex 6 (Manufacture of medicinal gases) and Annex 15 (Qualification and validation). These revisions aim to update guidelines to reflect current industry practices, new technologies, and ICH Q9(R1). Kazakhstan has also applied for PIC/S membership.

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.