EMEA Road Map: Information on Future GMP and GCP Inspections

GMP News No. 435

GMP News
15 July 2004
 

EMEA Road Map:
Information on Future GMP and GCP Inspections

 
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?
  

Recommendation of events

As mentioned above, EMEA is going to pay special attention to bioavailability studies.
If you are interested in getting more information about the requirements for bioavailabilty / bioequivalence studies, you are invited to participate in our joint conference ECA Quality in Dissolution Testing / Bioavailability / Bioequivalence. The conference will take place in Zurich /Switzerland from 29 September to 01 October 2004. Dr. Shein-Chung Chow, USA, one of the world's leading experts in the field of statistical evaluation of bioavailability/bioeqiuvalence studies will be among the speakers. If you wish any further information about the conferences, please click here.

 
Author:
Dr Barbara Jentges
CONCEPT HEIDELBERG
   

Literature

  • Discussion Paper: The European Medicines Agency Road Map to 2010: Preparing the Ground for the Future; Doc.Ref. EMEA/H/34163/03/Rev. 2.0; Link
  • Press release: EMEA sets out its road map to 2010; Doc.Ref. EMEA/D/9362/04/Final, 15 April 2004
  • Regulatory Affairs Journal Pharma, Voume 15, No 6, June 2004, page 432-434
  • EMEA press release, EMEA launches action plan for improvements for human medicines, 14 January 2004 (Link)
  • Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws. Regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in conduct of clinical trials on medicinal products for human use (Link)
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