European Medicines Agency plans public access to information on side effects

News 08/07/2011

The European Medicines Agency has published its plans for granting public access to the information held in its databases of the potential side effects of human and veterinary medicines.

The two policies published today explain the Agency's plans to release information held in its EudraVigilance and EudraVigilance Veterinary databases. These are the central repositories for reports of suspected adverse reactions related to medicines authorised in the European Economic Area and medicines being studied in clinical trials.

For human medicines, the Agency plans to produce monthly reports summarising the information held in EudraVigilance for all medicines authorised centrally via the Agency by the end of this year, extending this to searchable reports for all medicines by the end of 2012.

The Agency plans to make further improvements to the search and data-output functions and to supply the pharmaceutical industry with access to tools allowing the detection and analysis of signals on adverse reactions to human medicines by 2015, subject to budget being available.

For veterinary medicines, the Agency aims to produce monthly reports summarising the information held in EudraVigilance Veterinary, initially for all medicines authorised centrally. Currently, it plans to implement this in 2012, although this is subject to adequate resources being made available.

Marketing-authorisation holders will also have access to facilities for performing surveillance analysis as part of the development of EudraVigilance Veterinary 3, currently scheduled for delivery by the end of 2013.

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

The access policies were developed as part of the Agency's ongoing drive to increase its levels of transparency. They aim to contribute to the protection of human and animal health, by providing the Agency's stakeholders, including other medicines regulatory authorities, healthcare professionals, patients, consumers, the pharmaceutical industry and research organisations, with as much information as possible from these databases. They also take European Union legislation on the protection of personal data into account.

The Agency prepared the policies with input from its stakeholders. It has also prepared an PDF iconexplanatory note for the policy on human medicines to give additional information on its implementation.

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