Regulators – Pharmaceuticals

Regulators – Pharmaceuticals

Collaboration with the European Medicines Agencies (EMA)

The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU) responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU.

The EMA-EUnetHTA collaboration, which began in 2010 based on recommendations from the High-level Pharmaceutical Forum, aims to harness synergies between regulatory evaluation and health technology assessment (HTA) along the lifecycle of a medicine. Following initial work to improve the way data published by EU regulators as part of their benefit-risk assessment can contribute to relative effectiveness assessments by HTA organisations, additional topics of mutual interest were identified.

A first EMA-EUnetHTA work plan had been established for the years 2012-2015; a report on the outcomes of this joint work plan has been published in April 2016. Following up on the achievements and developments, a new joint work plan for the years 2017-2020 has been agreed. The overall goal of the collaboration is to improve efficiency and quality of processes, whilst respecting their respective remits and ensure mutual understanding and dialogue on evidence needs, to facilitate access to medicines for patients in the European Union. Areas for the EMA-EUnetHTA collaboration EMA and EUnetHTA have jointly identified several areas as focus of their European regulatory-HTA collaboration during 2017-2020. 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 feed into the implementation of the areas for collaboration identified in the reflection paper from the HTA network on Synergies between regulatory and HTA issues on pharmaceuticals and will be developed in close cooperation with the European Commission.

The identified priority areas for collaboration are:

  • Early Dialogue / Scientific Advice.
  • “Late dialogues” / peri-licensing advice.
  • Information exchange between regulators and HTA bodies.
  • Methodologies to identify the treatment eligible population.
  • Significant benefit vs. added therapeutic value for orphan medicines.
  • Unmet medical need and therapeutic innovation for priority setting.
  • Patient and clinician engagement.
  • Shared understanding of methodological approaches for design, analysis and interpretation of clinical trials and observational studies.
  • Population-specific or Intervention-specific areas.

 

Discussions take place at the bi-annual meetings between the EUnetHTA and EMA representatives, via participation of EMA as observer in relevant activities of the EUnetHTA Joint Actions, by mutual commenting on specific documents produced by either of the organisations.

Press releases:

 

EUnetHTA-EMA meetings:

 

Read more about EMA