GMP News No. 435
15 July 2004
On 23 March, 2004, the European Agency for Medicinal Products (EMEA; new name is European Medicines Agency, as stated in the new Community legislation) published the discussion paper The European Medicines Agency Road Map to 2010: Preparing for the Future (1, 2, 3).
This Road Map builds on the four main activities outlined in The Action Plan for Improvements for Human Medicines, a previous EMEA strategic document that was published in the beginning of 2004 (4). The 4 key objectives of the action plan were laid down as follows:
The recently published Road Map outlines in more detail how EMEA intends to implement the initiatives up to the year 2010.
The European Medicines Agency was established in 1995 and it's Mission
statement is "(
) to contribute to the protection and promotion
of public and animal health (
)". The agency works as a
network, bringing together the scientific resources of the Member States.
With the Road Map the agency lays down its strategy for the future development.
The agency's vision is to "(
) maintain and further develop
its position as one of the leading regulatory authorities, which is
science-driven, and transparent in the way it operates (
One prerequisite for the implementation of the new EMEA vision is to
strengthen the current networking model.
What are the strategies in the GXP area?
With regard to the current changing environment (EU enlargement, implementation of the EU Directive on Clinical Trials (5), introduction of new technologies and new approaches to the use of technology in the manufacturing and control areas), the EMEA faces particular challenges in the coming years. Therefore a European quality system for ensuring fundamental GXP provisions is being achieved in the GXP area (see attachment 8).
The overall aim of the agency is to create better understanding between assessors and GXP inspectors in order to avoid duplication of effort and to promote synergies that "( ) makes the best use of both community and international resources ( )". Through the GCP and GMP inspection services, the EMEA is going to work together with all 25 EU Member states to consolidate requirements and promoting EU wide quality systems.
On the GMP side, special emphasis is given on the joint audit
programme for EU GMP inspectorates, supported by appropriate training to
ensure that '(
) excellence can be guaranteed across an enlarged EU
On the GCP side, the agency will help to meet the challenge of implementation of the EU Directive on Clinical Trials (5) through the work of the GCP inspection services group on harmonisation of practices and procedures, development of common approaches, joint training initivatives and support to the clinical trial related databases. In the future, special attention will be paid to bioavailability studies.
Will EMEA reach their vision?
The consultation period, where contributions were welcomed in order to
stimulate debate over the road map, ended at 30 June 2004. It will be
interesting what kind of comments were being considered and finally
the question comes up: Will EMEA reach its vision?
Recommendation of events
As mentioned above, EMEA is going to pay special attention to
Dr Barbara Jentges