Preparations are underway at the European Medicines Agency together with European Member States and the European Commission, for the introduction of the new pharmacovigilance legislation in July this year. The new legislation will represent the biggest change to the legal framework since The Agency was founded in 1995. The Agency is finalizing their preparations for the inaugural meeting of the new Pharmacovigilance Risk Assessment Committee (PRAC), which is scheduled for 19 July 2012.
Stakeholders are kept up-to-date on the ongoing implementation process through The Agency's website and stakeholder meetings, including information on transitional arrangements for the pharmaceutical industry, consultations and guidance on new or revised processes, and information on ways in which patients and healthcare professionals can get involved in identifying and managing safety issues in European Member States. This information will be supplementary to the finalization of the implementing measures by the European Commission.
Adjunct to the establishment of PRAC, the mandate of the existing Co-ordination Group for Mutual Recognition and Decentralized Procedures - Human (CMDh) has also been revised to reinforce its role in pharmacovigilance, with meetings commencing as of September 2012 that will focus on its newly assigned responsibilities.
According to The Agency, the new urgent Union procedure for safety issues with regard to nationally and centrally authorized medicines in 2012 will be starting to operate, and it will implement the procedure for protocol approval of post-marketing safety studies and results management, however, at first these will apply only for centrally authorized medicines. Furthermore, The Agency will develop a revised process for the coordination of pharmacovigilance inspections during the year starting from July 2012 with the revised process for signal detection for centrally authorized medicines with support from The European Member States for nationally authorized products providing additional data.
Any patient in European Member States will be able to report suspected adverse drug reactions to his or her national medicines authority under the new legislation, a right that already exists in some Member States. Both, The Agency and Member States will cooperate to provide patients with information on direct reporting during 2012.
The Agency's and European Member States' transparency of all their pharmacovigilance activities will be raised substantially under the new pharmacovivgilance legislation, with the Agency increasing transparency of its processes and procedures through the publication of its agendas, recommendations, opinions and minutes from its scientific committees, which include the PRAC, the CMDh and the Committee for Medicinal Products for Human Use (CHMP). The Agency will also organize public hearings on request of the PRAC that will enable the public to openly discuss safety issues with the Agency. This will reinforce the Agency's current responsibility in ensuring the exchange of coherent and consistent messages on safety issues across Europe.
The Agency had a consultation with European industry associates in a workshop held on the 30 January 2012, and will subsequently publish details on the revised implementation of the electronic submission of information on all medicines for human use authorized or registered in the European Union (also known as Article 57 requirements) in February 2012.
The Agency will also publish its concept paper on the structure of good pharmacovigilance practice (GVP) in February, releasing the first wave of GVP modules for public consultation, and has just published a new implementation plan that provides detailed activities of the new pharmacovigilance legislation scheduled to be implemented in 2012 together with those activities that will be a key issue beyond 2012.
The highest priority will be assigned to activities that contribute to public health, followed by activities that increase transparency and improve communication, after which come those that simplify processes.
Starting in February, the Agency and its stakeholders will be communicating closely on development issues regarding the implementation of the new legislation.
by
Akshaya Srikanth
Pharm.D*
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