Last November 2023, a public consultation on the draft revised consolidated 3-year work plan for the Methodology Working Party (MWP) was launched by the European Medicines Agency (EMA) to ask for feedback and gather comments from all key stakeholders.
The MWP was established by the Committee for Medicinal Products for Human Use (CHMP) at EMA to leverage the cross-disciplinary expertise to support methodological innovation in global drug development and support advice and interpretation of complex methodology across (clinical) drug development. The Methodology Working Party workplan constitutes the roadmap of MWP activities based on evolving identified priorities.
EPTRI commented on the need to revise and update existing guidelines on pharmacogenomics, including relevant information for the paediatric population, as well as to provide indications on the use of real-world evidence (RWE)-based data applied to small populations. In addition, EPTRI emphasised the importance of providing continued input to the EU Pharma Legislation revision, specifically on the Orphan and Paediatric Regulations.
Following the opening of the public consultation, a MWP stakeholder interaction meeting was organised on 7 December 2023.
The main objectives of this meeting were to consolidate the comments received during the public consultation and to shape the updated MWP Workplan for the final endorsement for the Committee for Medicinal Products for Human Use (CHMP) preparatory and organisational matters (PROM) plenary meeting.
All the EPTRI comments have been given a positive response and will be included in the final draft of the MWP workplan.