Guideline on registry-based studies published

EMA has published guidance to provide key methods and good regulatory practices to pharmaceutical organisations on the planning and conduct of registry-based studies. This will help generate high-quality data from patient registries to support regulatory assessments. Experience gained from CHMP qualification opinions for two networks of registries and input collected during five workshops on specific patient registries organised by the Agency fed into the final guidance. This guideline contributes to transforming to the data-driven medicines regulation foreseen in the Big Data Steering Group Workplan, which implements the Network Strategy to 2025.

Related information:

Publication of the joint HMA-EMA Data Standardisation Strategy (DSS)

The European Medicines Regulatory Network Data Standardisation Strategy sets out the principles to guide the definition, adoption and implementation of data standards according to the European medicines regulatory network needs related to data submitted throughout the lifecycle of medicinal products. The creation of the strategy enables faster uptake of data standards across the EU, will contribute to improve data quality and enable data linkage and data analysis to support medicine regulation. It will support the creation and implementation of internationally applicable data standards in line with the data pillar of the network strategy to 2025.

EMA launches the ‘Regulatory Science Research Needs’ initiative

EMA has issued a list of regulatory science topics that need further research to close gaps and improve medicine development and evaluation to enable access to innovative medicines for patients. EMA has identified around one hundred specific topics in this Regulatory Science Research Needs list.

For both human and veterinary medicines, the topics have been divided into four categories. These are:

  • integration of science and technology in medicines development;
  • collaborative evidence generation to improve the scientific quality of evaluations;
  • patient-centred access to medicines in partnership with healthcare systems;
  • emerging health threats and availability/therapeutic challenges.

By publishing this list, the Agency seeks to stimulate researchers and funding organisations to consider addressing these topics in their research agendas and share their findings and results with regulators. By engaging in the Regulatory Science Research Needs initiative, researchers and funders will be able to see their findings translated into regulatory practice, medicines development and public health. Researchers and funders are invited to get in touch with EMA should they be interested in one of the topics on the list or the initiative in general.

EMA Initiates DARWIN EU Coordination Centre

The European Medicines Agency (EMA) is establishing a coordination centre to provide timely and reliable evidence on the use, safety and effectiveness of medicines for human use, including vaccines, from real world healthcare databases across the European Union (EU). Additionally, the center will be used to conduct scientific studies that are requested by medicines regulators and, later on, those that have been requested by other stakeholders.

The Erasmus University Medical Center Rotterdam will be working with EMA as a contractor on the establishment of the DARWIN EU Coordination Centre. More information is available on the EMA’s website.