EMA planning fundamental change in pharmacovigilance rules

The European Medicines Agency, together with the European Union 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 says it will finalize its preparations for the inaugural meeting of the new Pharmacovigilance Risk Assessment Committee (PRAC), planned for July 19, 2012.

The EMA will continue to inform stakeholders of the ongoing implementation process through its web site and stakeholder meetings. This will include consultation and guidance on new or revised processes, information on transitional arrangements for the pharmaceutical industry, and information on how patients and health care professionals can be involved in the detection and management of safety issues in European member states. This information will complement the implementing measures being finalised by the European Commission.

CMDh mandate revised