The European Medicines Agency has developed the “HMA-EMA Catalogues of real-world data sources and studies” website. The Agency maintains this website to collect and present in a single catalogue information about data sources, institutions, and networks to facilitate access thereto by researchers and potential study funders. In addition, the Agency maintains this website to collect and present information about studies to ensure compliance with legal requirements set out in Union pharmacovigilance legislation, increase transparency, reduce publication bias, promote the exchange of information and facilitate collaboration among stakeholders including academia, pharmaceutical companies and regulatory bodies.

Registration data source, institution, or network

When you register a data source, institution, or network, or update existing entries, you confirm that the information entered is true, accurate and not obsolete. Registration is also an acknowledgement that the information entered will be made available to the public via the RWD Catalogues website.  All provisions of the Privacy policy apply. 

It is the responsibility of each individual record holder to keep its record information up-to-date. Record owners may update their information at any time. By registering in the Catalogue of real-world data sources, you commit to review and update your entry(ies) regularly, and, as a minimum, at least every twelve (12) months. For that purpose, a periodic reminder to do this will be sent.

The Agency reserves the right to return any submission for registration deemed incomplete or inadequate or where the institution, network or data source does not comply with the present T&C or other technical requirements in force at that time.

Registration study 

Studies may be registered by the (primary) lead investigator conducting the study or any person on his/her behalf (e.g. contact person for scientific or public enquiries), or by a sponsor and/or marketing authorisation holder or any person on their behalf.

As the person registering a study or providing subsequent updates to existing study records you confirm that:

  • the provided information is true, accurate, current and complete;
  • the information provided may be used according to the Privacy policy;
  • you accept responsibility for all activities related to the use of your login details or password provided upon registration;
  • it is your responsibility to enter the information required for registration and to keep this information up-to-date at all times;
  • you commit to reviewing and updating your study records regularly;
  • you acknowledge that all information is accessible to the public via the HMA-EMA Catalogue of real-world data studies maintained by the Agency.

EMA reserves the right to reject applications for study registration deemed incomplete or inadequate. Communication will be dispatched either confirming the study has been accepted and published, or asking for further clarifications. 

For further information, please also consult the legal notice and cookies