EMA and EUnetHTA Release Collaboration Report

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The agencies detail the results of their three-year collaboration.

The European Medicines Agency (EMA) and the European network for Health Technology Assessment (EUnetHTA) published a report on April 14, 2016 on its three-year work plan spanning November 2012-December 2015. The report released by EMA and EUnetHTA focuses on reconciling regulatory and HTA requirements into one clinical development program. EMA says this will improve quality of the regulatory evaluation in addition to enhancing sharing experience and knowledge along the life span of medicines.

According to EMA, the joint collaboration aims to create synergies between regulatory evaluation and health technology assessment (HTA) along with the lifecycle of a medicine. The overall goal, EMA said in a press announcement, is to improve the quality of the processes.

Key achievements of the collaboration since 2012 cited in the report include:


  • Joint regulatory/HTA scientific advice/early dialogue for medicine developers to reduce duplication and to streamline and optimize the whole medicine development process.

  • Improved EMA assessment reports to address the needs of HTA bodies. EMA and EUnetHTA have changed the way information on the benefits and risks of medicine is presented in the European public assessment report.

  • Approaches for collection of data post authorization, with a number of initiatives exploring methods to generate and collect data.

  • Facilitating EUnetHTA’s pilot projects on effectiveness assessment of pharmaceuticals.

  • Discussion of the therapeutic indication for medicines.

EMA and EUnetHTA say they plan to continue their collaboration. Further areas for collaboration include: more structured interactions for marketing authorization applications, including pre-submission dialogue and exchange reports to support later HTA, and collaboration on the development of scientific guidelines of the design of clinical development programs in specific conditions.

Source: EMA