The European Medicines Agency, together with the European 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 will finalise its preparations for the
inaugural meeting of the new Pharmacovigilance Risk Assessment Committee
(PRAC), planned for 19 July 2012.
The Agency will continue to inform stakeholders of the ongoing
implementation process through its website 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 healthcare 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.
In addition to the establishment of the PRAC, the mandate of the existing
Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human
(CMDh) has been revised to strengthen its role in pharmacovigilance. This group
will begin meeting based on its new responsibilities from September 2012.
The Agency will begin to operate the new urgent Union procedure for safety
issues concerning nationally and centrally authorised medicines in 2012. The
Agency will implement the procedure for protocol approval of post-marketing
safety studies and results management initially only for centrally authorised
medicines, and will develop a revised process for the coordination of
pharmacovigilance inspections during the year.
The revised process for signal
detection for centrally authorised medicines will start as of July 2012, with
additional data support being provided to the European Member States for
nationally authorised products. With the new legislation, any patient in European Member States will be
able to report suspected adverse drug reactions to his or her national
medicines authority. This right already exists in some Member States. The
Agency will cooperate with the Member States on providing information to
patients on direct reporting during 2012.
The new pharmacovigilance legislation will significantly increase the
transparency of all pharmacovigilance activities of the Agency and the European
Member States. The Agency will increase the transparency of its processes and
procedures by publishing the agendas, recommendations, opinions and minutes
from its scientific committees, including the PRAC, the CMDh and the Committee
for Medicinal Products for Human Use (CHMP). At the request of the PRAC, the
Agency will organise public hearings allowing the public to engage with the
Agency on safety issues, and will strengthen its current role in ensuring
coherent and consistent messages on safety issues across Europe.
Following consultation with European industry associations at a workshop
held on 30 January 2012, the Agency will publish information on the revised
implementation of the electronic submission of information on all medicines for
human use authorised or registered in the European Union (also known as Article
57 requirements) in February 2012.
Also in February, the Agency will publish its concept paper on the
structure of good pharmacovigilance practice (GVP) and release the first wave
of GVP modules for public consultation.
The Agency has today published a new implementation plan detailing the
activities of the new pharmacovigilance legislation scheduled for
implementation in 2012 and those activities which will be the focus beyond
2012. Activities contributing to public health are given the highest priority,
followed by activities increasing transparency and improving communication, and
then those that simplify processes.
From February, the Agency will be communicating closely with its
stakeholders on developments related to the implementation of the new
legislation.