Which post-marketing database and studies does EMEA require.

The European process for assessment of pharmaceutical products is complex and presents with diVerent levels. There is the European level with two major procedures resulting in decisions on approval after applications to market a pharmaceutical product in European countries. One is the centralised procedure organised by the European Medicines Evaluation Agency (EMEA). The other one is the mutual recognition procedure performed by consensus between Member States. The decisive body on the European level for medicines for humans is the Committee for Proprietary Medicinal Products (CPMP) with representation of two members from each of the countries of the European Union. This expert body is supported by others (Working Parties) where specialist competence within each of the areas and from each of the member states is providing ample opportunities for exchange of expertise and consensus discussions (fig 1). Medical regulatory requirements including clinical eYcacy and clinical safety aspects are discussed and drafted within the EYcacy Working Party. This work is resulting in Concept Papers, Points to Consider, Notes for Guidance, or Scientific Advice to specific questions asked by applicants (fig 2). The objectives of these guidance documents are: x to give guidance to pharmaceutical companies in planning the clinical development of new compounds to demonstrate therapeutic eYcacy and clinical safety, x to harmonise the requirements among assessors and experts of the diVerent European National Regulatory Authorities in assessing data and documents, x to adjust regulatory requirements to the advances in the biomedical domain, x to contribute to the activities of the International Conference of Harmonization (ICH). It is important to realise that the work process is characterised by networking and by openness. The network is shown in figure 3 and the process exemplified by showing steps for drafting eYcacy guidance papers (fig 4). All kinds of expert knowledge, regulatory, medical schools, learned societies, patient care, hospital or ambulatory are getting chances to become included. Important interfaces to achieve this are provided by National Regulatory Authorities and by supranational Learned Societies. Decisions taken on the national level and within national procedures, which are still existing, normally have to take into consideration all aspects agreed upon on the European level. Here national bodies have important tasks to fulfill, too. At this stage of development of procedures and regulatory requirements in the European Union there are no guidance papers specifically on post-approval therapeutic aspects other than adverse drug reaction reporting procedures and evaluation of case reports. But resulting from legal requirements it is clear that additionally to guidance covering preapproval and post-approval issues altogether new aspects resulting from application experience have to be considered and documentation and evaluation have to become supplemented accordingly. The new aspects that should earn specific attention from manufacturers, medical doctors, pharmacists, and patients are especially those that could not be studied suYciently in the pre-approval period. Figure 1 The Committee on Proprietary Medicinal Products (CPMP) and its Working Parties. CPMP