EMA holds first stakeholder forum on the implementation of the new pharmacovigilance legislation

On 15 April 2011, the European Medicines Agency held a stakeholder forum on the implementation of the new pharmacovigilance legislation with a broad cross-section of participants including industry, patient and healthcare professional representatives and national medicines regulatory authorities.


This was the first in a series of stakeholder meetings taking place during 2011 and 2012, when the Agency aims to raise awareness of the requirements of the new legislation and promote the exchange of ideas, concerns and opinions.


During this first meeting, immediate feedback from stakeholders was received mainly in relation to the Agency's and Member States' technical contribution to draft European Commission implementing measures. Close co-ordination and co-operation with stakeholders will maximise the opportunities for a successful and efficient adoption of new requirements, which come into legal force in July 2012.

The discussions during the day highlighted several key aspects of the new legislation including:

  • changes to inspections and pharmacovigilance systems including the introduction of Pharmacovigilance System Master Files;
  • use of internationally agreed terminology, formats and standards for the performance of pharmacovigilance activities;
  • minimum requirements for monitoring data in EudraVigilance;
  • changes to Periodic Safety Update Reports (PSURs);
  • format and content of risk management plans;
  • new measures for transparency and communication including the creation of websites to highlight safety issues with medicines and the introduction of a public hearing process.

All presentations from the stakeholder forum have been published.


A second stakeholder forum will be held on 17 June 2011. Participants will include representation from similar groups to those present at the first meeting, and will be invited by the Agency as appropriate once agenda topics for the day have been finalised.


The new pharmacovigilance legislation, which amends existing legislation, was adopted in the European Union in December 2010. The legislation aims to save lives by strengthening the European-wide system for monitoring the safety of medicines. The new legislation forms part of a three-piece ‘pharmaceutical package’ and amends existing pharmacovigilance legislation contained in Directive 2001/83/EC and Regulation (EC) No. 726/2004. The remaining parts concerning falsified medicines and information to patients have not yet been adopted by the European Parliament and the European Council.


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