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:
- Reinforce the agency's scientific evaluation processes
- Further improve the transparency of the procedures
- Provide for a better functioning of its scientific committee, the
CPMP
- Strengthen the capacity of the agency's professional workforce to
equip them for a more scientific role in the future.
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.
Over the next few years, the EU Regulatory System will be confronted with
significant legislative (impact of the new Community legislation) and
institutional (impact of the EU enlargement) changes.
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.
In the Road Map, the agency discusses the strategy on how to achieve its
goals by focusing on six areas:
- Scientific Advice (Attachment 3)
- Scientific Assessment (Attachment 4)
- Post-Authorisation Activities (Attachment 5)
- Transparency and Communication (Attachment 6)
- Provision of Information to Patients (Attachment 7)
- GMP/GCP Practices ('GXP'; Attachment 8)
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
(…)" (1).
In order to achieve an EU-wide transparency as regards manufacturing
information about both finished products and starting materials, a
European wide database on manufacturing authorisations and inspection
information and a register for GMP certificates is achieved to be
introduced.
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?
