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EMA prepares for major changes to European pharmacovigilance legislation

New measures will encourage greater transparency and allow patients in any European Member State to report adverse reactions

New rules governing the monitoring, identification and assessment of adverse events caused by pharmaceuticals will be launched in Europe in July 2012.

The European Medicines Agency (EMA) has said the planned pharmacovigilance measures, which aim to improve public health protection, will bring the "biggest change to the legal framework since the establishment of the Agency in 1995".

The changes include allowing any patient in any European Member States the chance to report suspected adverse drug reactions to his or her national medicines authority – a right that only currently exists in some countries.

Leading the implementation of the legislation will be the newly formed Pharmacovigilance Risk Assessment Committee (PRAC), which will hold its first meeting on July 19, 2012.

This committee will compel the EMA to organise public hearings allowing the public to discuss safety issues with the Agency as part of increased transparency measures regarding the pharmacovigilance activities of the EMA and Member States.

These transparency measures will also see the EMA publish a full range of agendas, recommendations, opinions and minutes from its scientific committees.

The committees include the PRAC, the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) and the Committee for Medicinal Products for Human Use (CHMP).

The CMDh, which was set up in 2005 to examine any question relating to marketing authorisations of medicinal products in two or more Member States, will also see revisions to its mandate, giving the group more pharmacovigilance responsibility from September, 2012.

In addition, a revised process for the detection of risk signals in medicines will commence in July 2012, which will see extra data support being provided to European Member States for nationally authorised products.

Changes to the protocol approval of post-marketing safety studies and results management will be initiated by the EMA for centrally authorised medicines, and a modified process for the coordination of pharmacovigilance inspections will be developed over the course of this year.

The legislation also encourages the adoption of electronic records, with the EMA stating that by July 2, 2012, marketing authorisation holders must electronically submit to the Agency information on all medicinal products for human use authorised or registered in the Union. This information must follow a format set by the EMA.

All the pharmacovigilance measures were approved by the European Commission in late 2010, when the Commission concluded the current system was "complex" and had the "potential for duplication of effort, as well as the potential for confusion of responsibilities".

• More on the European Commission's new pharmacovigilance measures

3rd February 2012

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