The European Medicines Agency (EMA) and the European Network for Health Technology Assessment (EUnetHTA), a network for health-technology assessment bodies across Europe, have published a joint work plan that outlines key areas of collaboration for the next three years.

The EMA-EUnetHTA collaboration, which began in 2010, aims to intertwine regulatory evaluation and health-technology assessment (HTA) along the lifecycle of a medicine. The overall goal is to improve the efficiency and quality of processes and ensure mutual understanding and dialogue on evidence needs.

Some objectives of the new work plan include: (1) a new platform for parallel consultation, created in July 2017, to provide developers of medicines with simultaneous, coordinated regulatory and HTA advice on their development plans and facilitate alignment of data requirements; (2) the exchange of information on the outcome of the regulatory assessment at the time of marketing authorization (part of EUnetHTA’s new framework for the production of relative effectiveness assessments); and (3) post-licensing evidence generation tools, such as patient registries, which are being optimized to serve data needs for various decision-makers.

In addition, the EMA and EUnetHTA will further collaborate in a number of areas, including: exploring how HTA bodies and regulators apply the concepts of unmet medical need and therapeutic innovation in view of possible synergies; and understanding the conceptual similarities and differences between the benefit of orphan medicines versus their added therapeutic value.

The three-year work plan is complementary to actions foreseen in EUnetHTA Joint Action 3, which runs until 2020.

Furthermore, the activities in this work plan will be developed in close cooperation with the European Commission.

Source: European Medicines Agency