European program - Joint Action EU4Health: IncreaseNET project

The IncreaseNET project is funded under the European program - Joint Action EU4Health and has a three-year duration, with an expected conclusion on December 31, 2026. It involves 29 partners, mainly National Competent Authorities (NCAs) in the pharmaceutical sector, representing 27 EU/EEA countries and Ukraine.

The purpose of the project is to strengthen the capacities and competencies of the NCAs in the evaluation of medicines by providing them with tools to address the challenges posed by innovation, also aiming to ensure patients timely access to innovative, high-quality, effective and safe medicines.
The exchange of knowledge, ideas and best practices will contribute to strengthening the network of European Regulatory Agencies (ERMN), improving training offerings for assessors, optimizing existing capabilities and promoting innovation.

The main project activities include:

• Identification of existing capacities/competencies and areas for improvement;
• Development of methodologies and theoretical training for the continuous education of assessors;
• Implementation of on-the-job learning programs to foster the growth of new assessors;
• Encouragement and strengthening of collaboration among NCAs;
• Exploration of solutions for more efficient resource use;
• Identification of best practice in managing scientific and technological innovation;
• Strengthening collaboration between NCAs, academia, and research sectors in information exchange and harmonization of training guidelines.

The project is divided into 8 Work Packages (WPs):

• WP1 - Project management and coordination
• WP2 - Dissemination and communication
• WP3 - Evaluation
• WP4 - Sustainability and collaboration with EU-NTC
• WP5 - Delivery of training materials
• WP6 - On-the-job training program
• WP7 - Efficient use of resources
• WP8 - Supporting innovation

All activities will be carried out in close collaboration with the European Medicines Agency (EMA), the Heads of Medicines Agencies (HMA), and key groups such as the EU Network Training Centre (EU-NTC), Accelerating Clinical Trials in the EU (ACT EU), the Committee for Human Medicinal Products (CHMP), the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), the Committee for Advanced Therapies (CAT), the Biologics Working Party (BWP), and the EU Innovation Network (EU-IN).

The role of AIFA
Within Work Packages 7 and 8, AIFA is responsible for coordinating the following specific objectives:

• Identification of the most appropriate actions to avoid duplication of work and discrepancies in evaluations among Competent Authorities, specifically regarding bioequivalence studies (within WP7).
• Updating the technical-scientific skills of European regulatory authorities through training courses delivered by academia, focusing on innovative topics (within WP8).