Services and databases | European Medicines Agency (EMA)

Clinical trials in the European Union

A centralised system for managing clinical trials in the EU and EEA, with publicly available information on clinical trials granted or refused permission via the system

EMA Account Management

Used for creating and managing EMA user accounts, which users need for accessing certain services and systems managed by EMA

eSubmission

Used by pharmaceutical companies to submit regulatory information concerning marketing authorisations applications to the national competent authorities and EMA

European database of suspected adverse drug reaction reports

Contains suspected side effects reported by patients and healthcare professionals in the EU, with information on how to interpret them

European Shortages Monitoring Platform

Used by pharmaceutical companies and national competent authorities to gather information about medicine supply and demand in the European Union (EU) and European Economic Area (EEA)

HMA-EMA Catalogues of real-world data sources and studies

Helps regulators, pharmaceutical companies, and researchers in identifying the most suitable data sources to address specific research questions. Researchers also use it to register their observational studies.

IRIS

Used by pharmaceutical companies for handling product-related scientific and regulatory procedures with EMA, with certain information accessible to all visitors

Product Lifecycle Management Portal (PLM)

Used by pharmaceutical companies and regulators for managing medicine-related product data, with read-only access for visitors

Substance, product, organisation and referential (SPOR) data management services

Used by pharmaceutical companies and regulators for managing medicine-related master data, with read-only access to all visitors

Veterinary medicines information website

Information on authorised veterinary medicines across all EU / EEA countries, including their availability in specific countries