Mutual recognition procedure drugs

The mutual recognition procedure is an alternative means by which a marketing authorization may be sought. It is open to all drug types except products of biotechnology. Briefly, if this procedure is adopted by a sponsor, then the sponsor applies for a marketing licence not to the EMEA, but to a specific national regulatory authority (chosen by the sponsor). The national authority then has 210 days to assess the application. 

Mutual Recognition Procedure The Mutual Recognition Procedure is stated in Council Directive 93/39/EEC. In essence, once a drug is approved for marketing authorization by one member state, the company concerned can apply for marketing authorization in other member states through the mutual recognition procedure in place since 1998. 

Decentralized Procedure (DCP) The decentralized procedure was established as an application route in late 2005. This procedure is essentially a combination of the national and the mutual recognition procedures. The applicant chooses a reference member state to undertake the initial assessment. On completion of the RMS assessment, the concerned member states can put forward additional questions to those raised by the reference member state. If the questions are answered by the applicant to the satisfaction of the reference member state and concerned member states, the drug can be authorized. The benefit of the decentralized procedure is that all concerned member states are provided with the application dossier from the start of the procedure. 

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. 

Under the mutual recognition procedure, the applicant company usually ends up receiving national marketing authorisations from some or all of the national drug regulatory authorities to whom the dossier is submitted. The centralised procedure, on the other hand, is all or none , and under it the applicant company would receive a single marketing approval from the EMEA valid in all European Union countries. Rejection of an application under the centralised procedure means that the product cannot be marketed in any Member State. 

Mutual recognition procedure This applies to conventional drugs. Applications are made to individual Member States selected by the applicant. A system is put in place whereby mutual recognition of the evaluations is observed by other Member States. When there is a dispute between Member States on the issue of mutual recognition, the EMEA is called upon to arbitrate, and its decision is binding on the Member States. 

In Europe, inspections are conducted by member states on behalf of the European Union. For drugs approved under the centralized procedure, inspections are coordinated by the European Medicines Agency (EMEA refer to Sections 7.3 and 8.3). For countries that are members of the Pharmaceutical Inspection Cooperation Scheme (PIC/S see Section 7.13), there is mutual recognition of inspections performed by members. 

Until only a few years ago, a company intending to market a new drug product in the EU would submit a national NDA in each country in which authorization was sought. While national procedures may still be used in limited situations, such as for approval of product line extensions, a firm must choose the mutual recognition or centralized system. (We will not discuss the approval process for generic products.)... 

In the mid to later part of the 1990s, procedures were established to allow for more timely review and approval of marketing applications in the both European Union and the United States. The review process to be used and the timing for approval are defined by the local regulations, and are dependent upon the immediate therapeutic need for the product. The EU mutual recognition and centralized procedures and the U.S. Prescription Drug User Fee Act (PDUFA) will be discussed in more detail later in this chapter. 

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