EMA Prepares for 'Biggest Change' to Legal Framework Since Founding

Posted 02 February 2012 | By Alexander Gaffney, RAC 

The European Medicines Agency (EMA) announced on 2 February that it "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."

New pharmacovigilance legislation being enacted in July will harmonize adverse drug reaction reporting for all citizens across the EU, according to a statement released by EMA.

The legislation also makes the pharmacovigilance activities of EMA and EU member states significantly more transparent. The processes, procedures, agendas, recommendations, opinions and minutes from various advisory committees, including the Committee for Medicinal Products for Human Use (CHMP), will be published publicly after the legislation's implementation.

Meetings of the new Pharmacovigilance Risk Assessment Committee (PRAC) and the newly-mandated Co-odination Group for Mutual Recognition and Decentralised Procedures - Human (CMDH) will take place in July 2012. At that time, EMA "will begin to operate the new urgent Union procedure for safety issues concerning nationally and centrally authorised medicines."

As a result of the legislation, EMA will also issue "consultation and guidance on new or revised processes, information on transitional arrangements for the pharmaceutical industry, and information on how patients and healthcare professionals can be involved in the detection and management of safety issues in European Member States."


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