The European Medicines Agency (EMA) and the European Network for Health Technology Assessment (EUnetHTA) have published a joint work plan outlining key areas of collaboration for the next three years.
The EMA-EUnetHTA collaboration, which began in 2010, aims to harness synergies between regulatory evaluation and health technology assessment (HTA) along the lifecycle of a medicine whilst respecting their different remits. The overall goal is to improve the efficiency and quality of processes and ensure mutual understanding and dialogue on evidence needs. This facilitates improved access to medicines for patients in the European Union (EU).
“Regulators and HTA bodies have different responsibilities with regards to medicines. What unites us is a common goal of getting to the market more high-quality medicines that address unmet needs of millions of patients in the EU,” said EMA’s Executive Director, Professor Guido Rasi. “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.”
Some objectives of the new work plan include areas in which major progress has already been made, most notably:
- early dialogue / scientific advice: a new joint platform for parallel consultation was 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;
- information exchange at market entry: the exchange of information on the outcome of the regulatory assessment at the time of marketing authorisation as part of EUnetHTA’s new framework for production of relative effectiveness assessments (REAs);
- post-authorisation data generation: post-licensing evidence generation tools, such as patient registries, are being optimised to serve data needs for various decision-makers.
In addition, 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;
- understanding the conceptual similarities and differences between the significant benefit of orphan medicines versus their added therapeutic value.
These activities are directly related to the core activities of both organisations.