Finalised new joint work plan between EMA and EUnetHTA for 2017-2020

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.