Pharma group calls for regulatory improvements on trials and data

The European Medicines Agency should prioritise innovation in clinical trials, advice provision and use of real-world data in its strategic plan to 2025, a group representing pharmaceutical companies has said.

The European Federation of Pharmaceutical Industries and Associations published its response to the EMA’s call for input to its Regulatory Science to 2025 plan on 1 July. It said that the strategy, which covers human and veterinary medicines, comes at a “critical juncture for the EU regulatory system and its collaborators”, with new technologies and sources of evidence demanding responses from regulators.

EFPIA named its top three priorities for the EMA’s strategy as: fostering innovation in clinical trials, diversifying and integrating provision of regulatory advice along the whole pathway of treatment development, and promoting use of real-world data in decision-making.