European Medicines Agency and European Network for Health Technology Assessment Publish Joint Work Plan for 2017-2020
- 14/11/2017
- Articles
On 13 November 2017, the European Medicines Agency (“EMA”) and the European Network for Health Technology Assessment (“EUnetHTA”) published a joint work plan detailing areas for collaboration for the next three years. The collaboration between EMA and EUnetHTA began in 2010 and seeks to identify and make use of synergies between regulatory evaluation and health technology assessment across the lifecycle of a medicine. The immediate objective is to improve processes but the ultimate goal is to serve patients by increasing access to medicines.
The nine priority areas for collaboration are:
- Early dialogue / scientific advice – implementation of newly developed joint platform for parallel consultation;
- Late dialogues / pre-licensing advice – creation of post-authorisation evidence generation tools such as patient registries;
- Information exchange between regulators and HTA bodies;
- Methodologies to identify the treatment eligible population;
- Significant benefit v. 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.
While some of these proposed areas of collaboration are not new, the intensified partnership between the two bodies is hoped to help medicine developers improve clinical research and generate better evidence that will inform the decisions of regulators.
