The collaboration between the European Medicines Agency (EMA) and the European Network for Health Technology Assessment (EUnetHTA), which began in 2010, has been strengthened by publication of a joint work plan for the next three years. The goal is to streamline processes while improving the efficiency and quality, and to achieve a mutual understanding on evidence needs. Thus facilitating increased access to medicines for patients in the European Union.
Nine priority areas for collaboration have been identified:
- Early scientific advice/dialogue
- Peri-licensing advice/ “Late dialogues”
- Exchange of information between regulators and HTA bodies
- Development of processes to identify treatment-eligible populations
- Clarify the significant benefit vs. added therapeutic value with regards to orphan medicines to improve understanding
- Interpretation and application of unmet medical need and therapeutic innovation for priority setting
- Engagement between patients and clinicians
- Mutual understanding of approaches for design, analysis and interpretation of observational studies and clinical trials
- Intervention-specific or population specific areas.
Major progress has already been made in the following areas:
- Early scientific advice/dialogue – in July 2017 a new joint procedure for parallel consultation was implemented to provide synchronised regulatory and HTA advice on development plans and promote alignment of requirements for the data
- Exchange of information at market entry – providing the outcome of the regulatory assessment in a timely manner to support the production of joint relative effectiveness assessments (REAs)
- Generating data post-authorisation – optimising post-licensing evidence generation tools, for example, patient registries, to fulfil data needs for multiple decision-makers.
The activities that have been set out align with the core activities of both organisations, and the work plan aims to find a clear synergy between the EMA and EUnetHTA. The EMA-EUnetHTA collaboration will continue to explore future developments and monitor the work plan, whilst still appreciating their respective remits.
To read more about the three-year work plan, please click here.