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GMP News No. 435
15 July 2004
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:
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.
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.
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).
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?
Dr Barbara Jentges