IDAP, the IFPMA’s vision of innovation development and access pathways

The International Federation of Pharmaceutical Manufacturers and Associations proposed the IDAP (Innovation Development and Access Pathway) framework to streamline and, as far as possible, harmonise pathways for ensuring rapid authorisation and access to innovative medicines and vaccines, taking into account the specific characteristics of different countries.

2026 trends in pharmaceutical development

The introduction of artificial intelligence is one of the main drivers that will support the pharmaceutical industry’s final steps towards more innovative models, while facing legislative and regulatory innovation and geopolitical tensions. Biotech products are leading the way in innovative treatments

The UK’s new decentralised manufacturing framework

The new Decentralised Manufacturing Framework came into force on 23 July 2025. It enables the production of innovative medicines products such as cellular therapies close to the patients who will receive them. The framework covers both Point of Care manufacturing and Modular Manufacturing, and it requires prior authorisation and provides an alternative to traditional, centralised productions

The EU Commission’s Study on the deployment of AI in healthcare

The DG Santé published in August 2025 a very detailed study on issues to be solved to ensure the swift implementation of artificial intelligence in healthcare. The study provides a thorough analyses of the current deployment of AI systems from technical, clinical, regulatory and societal perspectives, offering suggestions on how to address open issues

Current status and perspectives in Joint Clinical Assessment

While the first two joint clinical assessments were launched in April 2025, a document published by the European Medicines Agency and the Heads of HTA Agencies Group addresses the remaining issues to reduce uncertainty in the parallel joint assessment of the first categories of medicines and medical devices covered by the HTA Regulation

New Approach Methodologies, the EMA’s horizon scanning report

The Horizon scanning report published by the European Medicines Agency and the Heads of Medicines Agencies discusses the challenges and opportunities for the development and implementation of New Approach Methodologies (NAMs) to support regulatory decision-making