EMA, EUnetHTA Sign Off on Three-Year Work Plan

Regulatory NewsRegulatory News | 13 November 2017 |  By 

The European Medicines Agency (EMA) and the European Network for Health Technology Assessment (EUnetHTA) on Monday detailed their priorities for the next three years in a joint work plan.

Much of the 2017-2020 work plan builds on previous and ongoing efforts to streamline processes between regulators and health technology assessment (HTA) bodies.

"By working together, EMA and EUnetHTA help medicine developers to improve clinical research and become more efficient in generating the evidence each of us needs for good decision-making," said EMA Executive Director Guido Rasi.

EMA says the work plan is complimentary to EUnetHTA's Joint Action 3, which seeks to create a sustainable model for scientific and technical cooperation for HTA, and will support efforts called for in a 2016 European Commission HTA Network reflection paper.


Specifically, the work plan lays out nine priority areas for collaboration between EMA and EUnetHTA:

  • Early  dialogue/scientific advice
  • "Late dialogues"/peri-licensing advice (advice given at the time of authorization)
  • Information exchange between regulators and HTA bodies
  • Methodologies to identify treatment-eligible populations
  • 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

Some highlights of the work plan include creating a single procedure for providing early joint scientific and HTA advice to drugmakers, optimizing postmarketing evidence generation requirements and implementing a process for exchanging information on regulatory outcomes to facilitate EUnetHTA's relative effectiveness assessments (REAs).

The work plan also seeks to clarify the concepts of "significant benefit" and "added therapeutic value" in the context of orphan drugs to improve understanding between regulators and HTA bodies.

Additionally, the work plan calls for EMA and EUnetHTA to boost their joint efforts in population- and intervention-specific areas, such as pediatric medicines, combination products, companion diagnostics and advanced therapies by engaging with research networks and notified bodies.

EMA, Work Plan


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