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.
