Centralized procedure , marketing

There are three procedures by which pharmaceutical products may gain a marketing authorization in the EEA. These are the National, Mutual Recognition, and Centralized procedures. 

The Committee for Medicinal Products for Human use (CHMP). This committee is composed of 35 technical experts drawn from the various EU member countries. It is primarily responsible for formulating the EMEA s opinion on any medicinal product being considered for marketing approval under the centralized procedure. 

Unlike the FDA, the EMEA itself does not directly undertake appraisals of drug dossiers submitted to support marketing authorization applications under the centralized procedure. Instead (as discussed in detail below), they forward the dossier to selected national EU regulatory bodies, who undertake the appraisal, and the EMEA makes a recommendation to approve (or not) the application based upon the national body s report. The overall role of the EMEA is thus to coordinate and manage the new system. The EMEA s annual budget is of the order of 120 million. The key objectives of the EMEA may be summarized as ... 

Under the centralized procedure, applications are accepted with regard to (a) products of biotechnology (b) NCEs (drugs in which the active ingredient is new). Biotech products are grouped as list A and NCEs as list B . Marketing approval application for biotech products must be considered under the centralized procedure, whereas NCEs can be considered under centralized or decentralized mechanisms. 

Upon receipt of a marketing authorization application under centralized procedures, the EMEA staff carry out an initial appraisal to ensure that it is complete and has been compiled in accordance with the appropriate EU guidelines (Box 4.4). This appraisal must be completed within 10 days, at which time (if the application is in order), it is given a filing date. The sponsor also pays an appropriate fee. The EMEA then has 210 days to consider the application. In the case of human drugs, the application immediately comes before the CPMP (which convenes for 2-3 days each month). 

Submission Details for Centralized Procedure This procedure was effective from 1995 with further amendments effective from November 2005. Six months before submission, the pharmaceutical company wishing to apply for marketing authorization via the Centralized Procedure notifies the EMEA of its intention and expected submission date. This notification is required to be accompanied by a number of items, for example ... 

Management and follow-up of marketing authorization applications under the centralized procedure,... 

In the centralized procedure, one license to market the drug in all of the EU is issued, and in principle there is only one evaluation of the dossier. In fact, both a rapporteur and corapporteur are appointed and eaeh assesses the dossier with its own... 

In summary, given the rigor of the centralized procedure and transparency of data required, the rationale is deemed to be important for maximizing the impact and political acceptability of the processes. It is, therefore, prudent to engage the services of a consultant who is well versed with the procedural method used by the Agency. By so doing, an applicant would be able to maximize the time and expense judiciously for all the pertinent parties concerned so that a new medicine may be brought to market within a reasonable period of time. 

Council Regulation 726/2004/EC (updates and expands the previous regulation 239/1993/EC), which mainly concerns the duties of the European Medicines Agency (EMEA), establishment of the Committee for Medicinal Products for Human Use (CHMP), and the scope and mechanisms of the centralized procedure for marketing authorization applications (MAAs) and pharmacovigilance issues. 

Four routes are available for obtaining a marketing authorization (MA) for a human medicinal product in the European Economic Area independent national procedure, mutual recognition procedure (MRP), decentralized procedure (DCP), and centralized procedure (CP) [5-7],... 

Independent National Procedure If a company wishes to market a product in one country only and there are no legal obligations to use a route other than the national one (which would apply if the type of drug or therapeutic area were within the scope of the centralized procedure), then an application can be made to one health authority, leading to a marketing authorization in that country alone. 

A CPMP member acts as rapporteur or corapporteur for centralized procedures and the CPMP gives an official opinion on whether an application for marketing is approvable or not. The EMEA is intimately involved in the management of this procedure up to the issue of the marketing authorization. The EMEA s involvement also includes preparation of the CPMP opinion in all 11 official EU languages. Quality management standards have been implemented for the preparation of scientific advice and opinions, and a... 

There are two European procedures for obtaining a marketing authorization in more than one country belonging to the EU. These are the Centralized Procedure and the Decentralized or Mutual Recognition Procedure. 

The Centralized Procedure must be used for biotechnology products and can be used for so-called high technology products as well as for new active pharmaceutical ingredients (i.e., products that have never before been approved for marketing). The Centralized Procedure is laid down in Council Regulation (EEC) N° 2309/93[ l and Directive 93/41/EEC.t ... 

National MAs were intended to be phased out after 1 January 1998, but it is likely that national approvals for marketing will continue beyond that date. The future foresees that all MAs within the European Union (EU) will have been issued under the rules governing medicinal products in the EC by virtue of the centralized procedure or the so-called mutual recognition or decentralized procedure (vide infra). 

Directive 2309/93 introduced further changes. It established a new body that is based in London, established on 1 January 1994, and two procedures for the obtaining entry to the markets of the member states, namely the multistate or decentralized or mutual recognition procedure and the centralized procedure see Figures 33.1 and 33.2, which show schematically the procedures which became operative on 1 January 1995. 

Under the mutual recognition procedure, the applicant company would receive a number of national MAs from national drug regulatory authorities. Under the centralized procedure, the applicant company would receive a single marketing approval from the EMEA, valid in all EU countries. 

Table 33.6 Variations and line extensions to marketing applications processed by centralized procedures...

Choice between centralized and decentralized procedures in the case of many NCEs (those for which the centralized procedure is not mandatory) involves many factors, and the decision is a strategic milestone involving medical practice, manufacturing plans, the nature of product, market forces, and the size, resources, and strengths of the sponsor in the EU (see Harman, 2004, for more details). 

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