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European regulatory aspects on new medicines targeted at treatment of rheumatoid arthritis
  1. Gottfried Kreutz
  1. Bundesinstitut für Arzreimittel und Medizinprodukte, Seestraβe 10, 13353 Berlin, Germany
  1. Dr Kreutz.

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Within the European Union a remarkable change has been taking place within the past five years that greatly influences the development of new medicines to become marketed products in the whole region or in some of their member states.

It is important for clinicians and basic scientists to realise these changes so that actual requirements be fulfilled by the documents supporting an application for approval in one, several, or all member states.

For this reason the idea of the organisers of this conference was welcomed to provide a forum for discussion between those professionals involved in clinical trials and those who are involved in regulatory decisions by setting up standard requirements or deciding on whether results presented by the applicant are meeting these requirements.

Understanding the organisational structure of the European regulatory house for the evaluation of medicines, the interactions between European institutions involved and to learn about the procedures is the aim of this presentation and all this is referring to rheumatoid arthritis as a major threat to health for many people.

The regulation of Medicines in the European Union is based on the 1957 Treaty of Rome and the Directives 65/ 65/ EEC1 and 75/318/EEC2 as amended by Directive 91/ 507/ EEC with the Commission as the governing institution.

These directives are transformed to national laws and this legal framework forms the regulatory framework of institutions and procdures involved.

Since 1995 the construction of the house is balanced and supported by three major institutional bodies, the Committee for Proprietary Medicinal Products (CPMP), the European Medicines Evaluation Agency (EMEA), and the Committee of Heads of Agencies (HoA).

The EMEA is providing the organisational, administrative and management facilities for the national agencies and experts to become involved in the European evaluation process and the preparation of decisions.

The HoA group, composed of Directors of national agencies or their directing representatives, are organising and providing regulatory support to make the mutual recognition of a firstly nationally approved medicinal product a reality that is based on critical appraisal of the first approving decision on one hand and comparability of applied criteria on the other.

The CPMP is the group of national representatives (two per member state) to organise and decide on all expertise required to provide scientifically valid answers to all scientific questions of relevance in evaluating medicinal products.

This is done either within the Committee or by involving working groups of experts permanently assigned as supportive to the CPMP, for example, those for pharmaceutical quality, toxicological safety, clinical efficacy and safety, biotechnological procedures, or pharmacovigilance, or nominated ad hoc as a task force for specific challenges.

Each of these expert groups may involve experts from national agencies or from the scientific community outside of these institutions.

With respect to the field of rheumatology the CPMP has become aware of major efforts in professional groups involved in patient treatment and in pharmaceutical companies to study and develop new medicines providing new approaches with new mechanisms of action and hopes for improved treatment in the future of osteoarthritis and rheumatoid arthritis, two highly disabling diseases with serious health implications to the population.

To make clear on the basis of current knowledge the requirements that have to be fulfilled when a pharmaceutical company applies for approval of a treatment in a specific indication with a pharmaceutical product clinical guidelines on clinical trial methodology have been developed.3 4

The Points to Consider on Clinical Investigation of Slow-acting Anti-rheumatic Medicinal Products in Rheumatoid Arthritis is reprinted with permission, as appendix. The purpose of a paper like this is threefold:

harmonise the view of assessors on the clinical requirements for licensing in this therapeutic area,
facilitate transparency of the assessment for products in this therapeutic area,
provide useful guidance to the pharmaceutical industry and their experts in planning/ conducting relevant clinical trials in this therapeutic area

The format of a points to consider document that has been chosen here results from the fact that this is a rapidly moving therapeutic area with many still controversial issues. A full guideline would not have been suitable in this situation.

The content will have to be modified according to increases in positive and more widely accepted knowledge. Rheumatologists and scientists contributing to their therapeutic abilities are invited to provide further evidence and sound knowledge.



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