EMA counts down to Introduction of new Pharmacovigilance Legislation

The European Medicines Agency EMA, together with the European Member States and the European Commission, is preparing for the introduction of the new pharmacovigilance legislation in July this year, which will bring the biggest change to the legal framework since the establishment of the Agency in 1995. Over the next five months, the Agency will finalise its preparations for the inaugural meeting of the new Pharmacovigilance Risk Assessment Committee (PRAC), planned for 19 July 2012.

With the new legislation, any patient in European Member States will be able to report suspected adverse drug reactions to his or her national medicines authority. This right already exists in some Member States. The Agency will cooperate with the Member States on providing information to patients on direct reporting during 2012.

The new pharmacovigilance legislation will significantly increase the transparency of all pharmacovigilance activities of the Agency and the European Member States. The Agency will increase the transparency of its processes and procedures by publishing the agendas, recommendations, opinions and minutes from its scientific committees, including the PRAC, the CMDh and the Committee for Medicinal Products for Human Use (CHMP). At the request of the PRAC, the Agency will organise public hearings allowing the public to engage with the Agency on safety issues, and will strengthen its current role in ensuring coherent and consistent messages on safety issues across Europe.

Source: EMA Press Release