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The Role of the EU National Agencies in European Regulatory Affairs

Some readers may be surprised to learn that the DIA annual US meeting provides a very good opportunity to learn about what's happening in European regulatory affairs. This year's DIA meeting held in June in Chicago, was no exception. Speakers included key personnel from the European Commission, the European Medical Evaluation Association (EMEA), the Committee for Proprietary Medicinal Products (CPMP) and various European national agencies. I was privileged to be able to chair one of the sessions in the regulatory affairs track. The aim of the session was to discuss the role of the national agencies in European regulatory affairs today. The role of these national agencies has changed considerably over the last few years, as discussed below.

When I started working in European regulatory affairs in 1989 it was usual to submit separate national dossiers to each EU member state (MS). In most cases these dossiers would be basically similar but they would be tailored to meet the specific requirements of each country. However, it was possible to submit for different indications in different member states, for example, depending on medical practice in that particular country.

Then in 1995 came the introduction of the centralised and mutual recognition (MR) systems. One of the key points of both of these systems is that they require identical dossiers to be submitted to each MS and at the end of the process either a single EU licence is granted (centralised system) or identical licenses are granted in all member states (MR system). Therefore, it is no longer possible to have different indications in different countries and the summary of product characteristics must be identical throughout the EU.


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By Ruth Paul, Regulatory Manager at Simbec Research Ltd

Ruth Paul is Regulatory Manager for Simbec Research Ltd, a full service CRO based in the UK. Since gaining a BSc in Biochemistry in 1989, Ruth has worked in regulatory affairs for both pharma and CROs.

Ruth has been responsible for preparing and submitting many marketing authorisation applications in Europe, using both the mutual recognition and centralised procedures.

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