Information about drugs’ side effects is set to be made more readily available to patients and healthcare professionals across Europe.
As part of a drive to become more transparent, the European Medicines Agency plans to grant public access to EudraVigilance, its pharmacovigilance database for human medicines, as well as to its animal medicines database EudraVigilance Veterinary.
By the end of 2011 the agency will produce monthly reports summarising all adverse reactions data it holds for EMA-authorised human medicines. The reports will be extended to include all human medicines by the end of 2012, it says.
Similar reports will be produced for EMA-authorised veterinary medicines in 2012, subject to the required funding being available.
In its "EudraVigilance access" policies, the EMA also sets out three-year plans to: improve the searchability of the EudraVigilance databases; make search results more user-friendly; and provide drug companies with tools to analyse the database contents, so they can more easily monitor the safety of their drugs.
The policies were drawn up with input from stakeholders, including pharmaceutical industry representatives and the heads of medicines agencies across Europe, and will be implemented once the necessary changes have been made to European legislation.
Thursday, July 14, 2011
Side effects data to be more accessible in Europe | PJ Online
via pjonline.com
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