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.

Latest EMA’s updates on the use of RWE in regulatory decision-making

The third annual report on the integration of real-world evidence (RWE) into regulatory decision-making shows a marked increase in the number of RWE studies conducted by the three pathways for generating RWE, the European consortium DARWIN EU, the framework contract (FWC), and in-house EMA studies. The PRAC Committee gave rise to the higher number of requests in the monitored period

EMA guideline on investigational ATMPs

The guideline adopted by EMA’s CHMP Committee on 20 January 2025 will come into force on 1 July. It discusses in detail all the different aspects to be considered during the development of an investigational advanced therapy medicinal product, both in exploratory and confirmatory studies, in order to prepare a submission dossier adequate to support application for marketing authorisation

The FDA’s Advanced Manufacturing Technologies Designation Program

The Advanced Manufacturing Technologies Designation Program aims to accelerate the implementation of novel manufacturing technologies and the application of existing ones to new contexts of use. The FDA Guidance for Industry, published at the beginning of January 2025, describes the entire process of submitting a request for AMT designation and its contents

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

PIC/S’ new guidances on remote and hybrid inspections

Two new guidance published by the Pharmaceutical Inspection Co-operation Scheme (PIC/S) discuss the different types of remote assessment, including hybrid inspections, and provide a harmonised approach to their conduct. The PIC/S also revised its guideline for the accession to the Scheme by interested regulatory agencies