Massive amounts of data are generated on a daily basis that could potentially be harnessed to support medicines regulation. The European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) set up a joint task force to describe the big data landscape from a regulatory perspective and identify practical steps for the European medicines...

HumanVeterinaryCorporateData on medicinesInnovationResearch and development

The Committee for Advanced Therapies (CAT) is the committee that is responsible for assessing the quality, safety and efficacy of advanced-therapy medicines.

EventHumanAdvanced therapiesInnovation

The European Sales and Use of Antimicrobials for Veterinary Medicine Working Group (EUSAvet) provides strategic guidance and recommendations to the European Medicines Agency (EMA) and its Committee for Veterinary Medicinal Products (CVMP). This guidance refers to the collection and analysis of data on sales volumes of veterinary antimicrobials and...

VeterinaryAntimicrobial resistance

The role of the European Medicines Agency's (EMA) Executive Steering Group on Shortages and Safety of Medicinal Products is to ensure a robust response to medicine supply issues caused by major events or public-health emergencies. It coordinates urgent actions within the European Union (EU) to manage medicine supply issues and issues related to the...

HumanVeterinaryInnovation

The European Medicines Agency (EMA) is a member of the International Coalition of Medicines Regulatory Authorities (ICMRA). ICMRA is a voluntary, executive-level entity of worldwide medicines regulatory authorities set up to provide strategic coordination, advocacy and leadership.

HumanCOVID-19Antimicrobial resistanceMedicines