Consultation open on the revision of GMP’s Chapter 1

Comments on the draft revision of Chapter 1 of the Good Manufacturing Practices must be submitted by 3 December 2025. The revision aims to update this fundamental text in light of the more recent advancements in pharmaceutical manufacturing, so to better ensure the ef-fectiveness and safety of medicinal products. The EIPG will liaise with member associations to submit a joint response to the draft text.

The EU AI Act: compliance obligations and business opportunities in 2025

As of February 2, 2025, the first binding provisions of the European Union's AI Act have come into force, marking a crucial milestone in AI regulation. European companies must comply with bans on unacceptable AI practices and implement AI literacy programs for their employees. This article examines the February 2025 updates, their impact on businesses, and the strategic opportunities arising from compliance

ICH E6(R3): a new era for Good Clinical Practice in industrial pharmacy

The latest revision of the International Council for Harmonisation (ICH) Guideline for Good Clinical Practice (GCP), ICH E6(R3), represents a significant advancement in the regulation of clinical trials. This update introduces a modernized, risk-based, and flexible approach to trial conduct, aiming to enhance data integrity, patient safety, and operational efficiency. This article examines the key changes in ICH E6(R3), focusing on its impact on industrial pharmacists involved in clinical research and drug development.