EMEA Road Map: Information on Future GMP and GCP Inspections

GMP News No. 435

GMPNews
15 July 2004
 

EMEARoad Map:
Information on Future GMP and GCP Inspections

 
On 23 March, 2004, the European Agency for Medicinal Products (EMEA; newname is European Medicines Agency, as stated in the new Communitylegislation) published the discussion paper The European MedicinesAgency Road Map to 2010: Preparing for the Future (1, 2, 3).

This Road Map builds on the four main activities outlined in TheAction Plan for Improvements for Human Medicines, a previous EMEAstrategic document that was published in the beginning of 2004 (4). The 4key 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, theCPMP
  • Strengthen the capacity of the agency's professional workforce toequip them for a more scientific role in the future.

The recently published Road Map outlines in more detail how EMEAintends to implement the initiatives up to the year 2010.

The European Medicines Agency was established in 1995 and it's Missionstatement is "(…) to contribute to the protection and promotionof public and animal health (…)". The agency works as anetwork, bringing together the scientific resources of the Member States.
Over the next few years, the EU Regulatory System will be confronted withsignificant legislative (impact of the new Community legislation) andinstitutional (impact of the EU enlargement) changes.

With the Road Map the agency lays down its strategy for the futuredevelopment.

The agency's vision is to "(…) maintain and further developits position as one of the leading regulatory authorities, which isscience-driven, and transparent in the way it operates (…)".One prerequisite for the implementation of the new EMEA vision is tostrengthen the current networking model.
In the Road Map, the agency discusses the strategy on how to achieve itsgoals 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 ofnew technologies and new approaches to the use of technology in themanufacturing and control areas), the EMEA faces particular challenges inthe coming years. Therefore a European quality system for ensuringfundamental GXP provisions is being achieved in the GXP area (seeattachment 8).

The overall aim of the agency is to create better understanding betweenassessors and GXP inspectors in order to avoid duplication of effort andto promote synergies that "(…) makes the best use of bothcommunity and international resources (…)". Through the GCP andGMP inspection services, the EMEA is going to work together with all 25 EUMember states to consolidate requirements and promoting EU wide qualitysystems.

On the GMP side, special emphasis is given on the joint auditprogramme for EU GMP inspectorates, supported by appropriate training toensure that '(…) excellence can be guaranteed across an enlarged EU(…)" (1).
In order to achieve an EU-wide transparency as regards manufacturinginformation about both finished products and starting materials, aEuropean wide database on manufacturing authorisations and inspectioninformation and a register for GMP certificates is achieved to beintroduced.

On the GCP side, the agency will help to meet the challenge ofimplementation of the EU Directive on Clinical Trials (5) throughthe work of the GCP inspection services group on harmonisation ofpractices and procedures, development of common approaches, joint traininginitivatives and support to the clinical trial related databases. In thefuture, special attention will be paid to bioavailability studies.

Will EMEA reach their vision?

The consultation period, where contributions were welcomed in order tostimulate debate over the road map, ended at 30 June 2004. It will beinteresting what kind of comments were being considered – and finallythe question comes up: Will EMEA reach its vision?
  

 
Author:
Dr Barbara Jentges
CONCEPT HEIDELBERG
   

Literature

  • Discussion Paper: The EuropeanMedicines Agency Road Map to 2010: Preparing the Ground for theFuture; Doc.Ref. EMEA/H/34163/03/Rev. 2.0; Link
  • Press release: EMEA sets out its roadmap 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 launchesaction plan for improvements for human medicines, 14 January 2004 (Link)
  • Directive 2001/20/EC of the EuropeanParliament and of the Council of 4April 2001 on the approximation of the laws. Regulations andadministrative provisions of the Member States relating to theimplementation of good clinical practice in conduct of clinical trialson medicinal products for human use (Link)

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