EMA & HMA Joint Strategy 2021-2025

Published on 8 December, the European Medicines Agency (EMA) and Heads of Medicines Agency (HMA) Joint Strategy looks into six strategic focus areas: (1) Availability and accessibility of medicines, (2) Digital tools and digital transformation, (3) Innovation, (4) Antimicrobial resistance, (5) Supply chain challenges, and (6) Sustainability of the Network.

The document lays down four main goals to be achieved by 2025:

• Catalyse the integration of science and technology in medicines development and ensure that the agencies have sufficient competences to support innovators in various phases of medicines development;
• Foster collaborative evidence generation – improving the scientific quality of evaluations and ensuring the generation of evidence useful to all actors in the lifecycle of medicines, including HTAs, and pricing and reimbursement authorities;
• Enable and leverage research and innovation in regulatory science;
• Enhance collaboration with other stakeholders including medical device experts, notified bodies, SMEs and research/academic groups.

When it comes to rare diseases, the report acknowledges the support real-world data may bring to contribute to best document the regulatory assessment and the quality and robustness of the scientific evidence supporting the marketing authorisation;

When it comes to ATMPs, the paper reflects on the necessity to foster capacity building and develop expertise at regulatory and HTA agencies to cope with the increasing number of ATMPs seeking approval.