European Union mutual recognition

Thus, as for the European Union, the requirements are based on accreditation, proficiency testing, the use of validated methods of analysis and, in addition, the formal requirement to use internal quality control procedures which comply with the Harmonised Guidelines. Although the EU and Codex Alimentarius Commission refer to different sets of accreditation standards, the ISO/IEC Guide 25 1990 and EN 45000 series of standards are similar in intent. It is only through these measures that international trade will be facilitated and the requirements to allow mutual recognition to be fulfilled will be achieved. 

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. 

When an applicant has obtained one national authorisation (within an European Union country), any ongoing assessment of that product in other EU Member States is suspended and the first authorisation granted is entered for mutual recognition by all or selected (depending on the choice of the applicant) Member States. 

Requires FDA support of efforts to move towards the acceptance of mutual recognition agreements between the European Union and the United States. 

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). 

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. 

The European Medicines Agency (EMEA) is a decentralized body of the European Union created with the objective to harmonize regulatory activities in Europe. EMEA began its activities in 1995, when the European system for authorizing medicinal products was introduced, providing for a centralized and a mutual recognition procedure. Its main responsibility is the protection and promotion of public and animal health through the evaluation and supervision of medicines for human and veterinary use. 

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. 

One way in which GxP regulators can assist in this process is to harmonize their GxP requirements. The European Union s (EU) GxP Directive, which has already been adopted by countries outside the European Union, has shown that harmonization can work. Mutual Recognition Agreements (MRAs) between EU national regulatory authorities and the FDA offer a similar opportunity for harmonization across the Atlantic. 

Notified bodies are independent testing laboratories and/or certification bodies recognized in the European Union to perform tests and issue reports and certificates on conformity. These bodies are generally referred to as notified bodies. Depending on the directive an accredited body may be referred to as a notified body, competent body, certification body, third party, or other (see Notified Bodies and Third Parties in Chapter 4). Test reports and certificates issued by accredited bodies attest to a product s or system s conformity to the relevant standards. These reports and certificates are the basis for mutual recognition of test results and build consumer confidence in a product s conformity. 

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