European Medicines Agency and U.S. Food and Drug Administration (FDA) launch Good Clinical Practice Initiative
LONDON, Aug. 3, 2009--The European Medicines Agency and the FDA have agreed to launch a joint initiative to collaborate on international Good Clinical Practice (GCP) inspection activities. This initiative comes under the scope of the confidentiality arrangements between the European Commission, the European Medicines Agency and the US FDA. The objectives of the initiative include the sharing of information on inspection planning, policy and outcomes and the conduct of collaborative inspections.
This initiative is an important contribution to ensuring the
protection of clinical-trial subjects in the context of the
increasing globalisation of clinical research. The European
Medicines Agency and the FDA will start their new initiative with
an 18-month pilot phase on 1 September 2009.
Announcing this pilot Thomas Lönngren, the European
Medicines Agency’s Executive Director said: "This important
initiative demonstrates the increasing collaboration between the
European Medicines Agency and the FDA. It marks an important step
to the building of a global regulatory network for supervision of
clinical trials. By working together in a collaborative and
synergistic manner GCP inspection resources can be used more
efficiently."
Key objectives of the FDA-European Medicines Agency GCP
initiative will be:
?? To conduct periodic information exchanges on GCP-related
information in order to streamline sharing of GCP inspection
planning information, and to communicate timely and effectively on
inspection outcomes.
?? To conduct collaborative GCP inspections by sharing
information, experience and inspection procedures, cooperating in
the conduct of inspections, and sharing best-practice
knowledge.
?? To share information on interpretation of GCP, by keeping
each regulatory agency informed of GCP-related legislation,
regulatory guidance and related documents, and to identify and act
together to benefit the clinical research process.
Applicants interested in volunteering to participate in a
collaborative inspection during the pilot phase can contact the
European Medicines Agency or the FDA. Contact point for the
European Medicines Agency is Dr Ana Rodriguez, Inspections Sector,
at GCP@emea.europa.eu.
-- ENDS --
Notes:
1. More detailed information about the EMEA-FDA GCP Initiative
can be found here.
2. The confidentiality arrangements allow the European
Commission/European Medicines Agency and the FDA to exchange
information as part of their regulatory processes. The types of
information covered by the arrangements include legal and
regulatory issues, scientific advice, orphan-drug designation,
inspection reports, marketing-authorisation procedures and
post-marketing surveillance. They cover medicinal products that are
subject to evaluation or are authorised under the centralised
procedure. In addition, they cover medicines authorised at national
level by the EU Member States that are subject to EU arbitration
and referral procedures.
3. This press release, together with other information on the
work of the EMEA, can be found on the EMEA website:
www.emea.europa.eu
Media enquiries only to:
Martin Harvey Allchurch or Monika Benstetter
Tel. (44-20) 74 18 84 27, E-mail
press@emea.europa.eu
www.emea.europa.eu/pdfs/general/direct/internationalcoop/EMEA_FDA_GCP_Initiative_2009.pdf
Posted: August 2009
