EMA to make public side-effects in EudraVigilance database by end of 2011

The European Medicines Agency by the end of 2011 plans to start granting public access to information in its EudraVigilance database on potential side-effects of certain human drugs¹.

The EMA says monthly summary reports of suspected adverse drug reactions information held in the database for all human medicines authorised through the centralised procedure will be made available to healthcare professionals and the general public^2,3. By the end of 2012, the agency intends to publish searchable, data-protected safety reports for all human medicinal products independent of the authorisation procedure.

Subject to adequate resources, it also plans to produce monthly reports summarising information on suspected adverse reactions for centrally authorised veterinary drugs held in its EudraVigilance Veterinary database⁴. The two access policies are part of the agency's ongoing drive to increase its levels of transparency⁵.

Subject to availability of funds, the EMA says it plans to make further improvements to the search and data-output functions of the EudraVigilance database by 2015. By this time, it also intends to supply the pharmaceutical industry, drug sponsors and research organisations with access to tools that would allow the detection and analysis of signals on adverse reactions to human medicines.

For veterinary medicines, agency plans to provide marketing authorised holders with access to facilities for performing surveillance analysis as part of the development of EudraVigilance Veterinary version 3, which is currently scheduled for delivery by the end of 2013.

To successfully implement these access policies, the EMA points out that a number of pre-requisites must be fulfilled to ensure high quality and reliable data outputs. These pre-requisites are being addressed in the context of the agency's EudraVigilance Data Quality Management project, which started in September 2010 and is expected to run for a period of four years.

For its part, the EMA wants to ensure that the phased implementation of its EudraVigilance access policy is as cost-effective as possible, until enhanced EudraVigilance functionalities⁶ that must be implemented in the context of the new pharmacovigilance legislation are made available.

For both human and veterinary medicines, the EMA says it will consider providing access to data for research purposes on a case-by-case basis in line with the agency's objective of protecting public health.

Last year, the European Ombudsman, in response to a complaint by an Irish citizen, criticised the EMA for its failure to provide public access to information on adverse drug reaction reports concerning an anti-acne drug, Roaccutane (isotretinoin)⁷. The Ombudsman asked the agency to review its transparency policy so that the public may have access to suspected serious drug adverse reaction reports, regardless of the form in which they are held in the database.

References

1. EMA, press release, 8 July 2011, www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2011/07/news_detail_001299.jsp&murl=menus/news_and_events/news_and_events.jsp&mid=WC0b01ac058004d5c1&jsenabled=true

2. EMA, EudraVigilance access policy for medicines for human use, 8 July 2011, www.ema.europa.eu/docs/en_GB/document_library/Other/2011/07/WC500108538.pdf

3. EMA, Explanatory note: EudraVigilance access policy for medicines for human use, 8 July 2011, www.ema.europa.eu/docs/en_GB/document_library/Other/2011/07/WC500108540.pdf

4. EMA, EudraVigilance access policy for medicines for veterinary use, 8 July 2011, www.ema.europa.eu/docs/en_GB/document_library/Other/2011/07/WC500108533.pdf

5. EMA policy on allowing access to EudraVigilance data imminent, Regulatory Affairs Pharma, 30 June 2011

6. Marr A, EMA mandates Eudravigilance medicinal product dictionary for all authorised products in Europe, Regulatory Affairs Pharma, 4 July 2011

7. EMA told to broaden access to ADR reports – update, Regulatory Affairs Pharma, 11 May 2010