New cancer therapies targeting tumours' genetic and molecular features instead of the sites of origin in the body are being developed. Regulators have raised the need to explore the possible data sources that could be used to gather long-term data on the safety and effectiveness of these innovative treatments for which only limited information is available at the time of authorisation.
In November 2019, the European Medicines Agency (EMA) hosted a multi stakeholder workshop including participants from regulatory agencies, registries groups, academia, industry, health technology agencies, health care professionals and patients with the objectives to agree on:
The EMA has published the report of the workshop summarizing the observations made by the participants on the use of registry data to support regulatory benefit-risk evaluation of these cancer therapies, highlighting aspects that should be considered by all stakeholders to facilitate the use of data collected by cancer registries. The workshop report is without influence on any EMA committee opinion on any products under evaluation or authorised in the European Union.