EMEA,

Complete an EMEA table (4) by beginning at the system boundary and evaluating the equipment items in the order these appear in the process. 

An EMEA table contains a series of columns for the equipment reference number, the name of the piece of equipment, a description of the equipment type, configuration, service characteristics, etc, which may impact the fadure modes and/or effects, and aflst of the fadure modes. Table 2 provides a Hst of representative fadure modes for valves, pumps, and heat exchangers. The last column of the EMEA table is reserved for a description of the immediate and ultimate effects of each of the fadure modes on other equipment and the system. 

Failure Mode and Effects Analysis. The system design activity usually emphasizes the attainment of performance objectives in a timely and cost-efficient fashion. The failure mode and effects analysis (FMEA) procedure considers the system from a failure point of view to determine how the product might fail. The terms design failure mode and effects analysis (DFMEA) and failure mode effects and criticaUty analysis (EMECA) also are used. This EMEA technique is used to identify and eliminate potential failure modes early in the design cycle, and its success is well documented (3,4). 

The EMEA begins with the selection of a subsystem or component and then documents all potential failure modes. Their effect is traced up to the system level. A documented worksheet similar to Eigure 4 is used on which the following elements are recorded. 

Eailure Mode and Effects Analysis (EMEA) A failure identification methodology where the failure modes of a component sub-system are identified. An analysis of these failure modes on the safety of the entire system is performed. 

Figure 2.6 The EMEA mission statement and principal activities (reproduced with permission of EMEA).

Executive responsibility for the administration of regulations at national level is divested in dedicated agencies. Although distinct from government departments, the Ministers of Health are the usual political masters of these national Competent Authorities. Eor example, the authority in Ireland is known as the Irish Medicines Board (IMB) and it covers both drugs and devices. Similar to the EMEA, the authorities are scientific and technical in orientation and are guided by various advisory panels. Their main tasks include ... 

Evaluation of applications for drug marketing authorisations made either directly to the national authority or indirectly via the centralised procedure to the EMEA... 

European Medicines Agency non-harmonised guidance documents http //www.emea.europa.eu/htms/human/humanguidelines/nondinical.htm. 

It is worthwhile to note that, in the US, where the applicant will just be dealing with a single authority, there is no need to re-submit data that was previously submitted as part of an IN D application to conduct clinical trials. Instead, the applicant can cross-reference the IND file. This does not apply in Europe, because clinical trial applications will have been submitted to individual Competent Authorities, whereas marketing authorisation applications are usually submitted either centrally to the European Medicines Agency (EMEA) or collectively to a number of Competent Authorities. Thus, the files need to be self-supporting. 

The procedures for obtaining a Community marketing authorisation are defined in EC Regulation No. 726/2004. The types of human-use medicinal products for which the procedure may be used are shown in Eigure 6.14. The applicant should notify the EMEA of their intention to submit an application at least 7 months... 

The applicant must submit complete copies of dossier to the EMEA, and directly to each of the rapporteurs. The EMEA are allowed 14 days to validate the application to ensure that it is complete and in accordance with the regulations, after which the rapporteurs can commence the scientific evaluation. The review process involves considerable feedback between the rapporteurs, the CHMP and the applicant, central to which can be achieving agreement on the final text of the SPC, labels and leaflet. The rapporteurs are required to deliver preliminary assessment reports to the CHMP within 80 days of the start of the review process. The applicant is also copied on the report. Over the next 40 days issues raised in... 

List of questions issued to applicant (CHMP/EMEA)---------- ... 

Opinion transferred to Commission (EMEA) Product irifo (MS)... 

Applications to establish MRLs for new pharmacologically active substances must be submitted to the European Medicines Agency (EMEA) at least 6 months in advance of an application for a marketing authorisation. In order to avoid delays, manufacturers are advised to submit an application once all the necessary data are available, as a product authorisation carmot be granted unless established MRLs are in place. The EMEA should be notified of the intent to submit an application 3 to 4 months in advance of the anticipated date, so that a Rapporteur and Co-Rapporteur can be appointed from among the members of the Committee for Veterinary Medicinal Products (CVMP). 

The review of MRL applications is similar to that for centralised marketing authorisations conducted by the EMEA, in that rapporteurs are responsible for the hands-on evaluation, which is then reported back to the CVMP for consideration. If there are outstanding issues, a list of questions is forwarded to the applicant for his or her response. Otherwise, a formal opinion is prepared and presented to the Commission for legal implementation as a decision. The maximum time allowed to deliver a CVM P opinion is 120 days, excluding the time taken for an initial validation of the application and review of responses form the applicant where necessary. 

In Europe, a sponsor may request an accelerated review of a marketing authorisation by the EMEA on grounds that the product is of major interest to public health, particularly from the viewpoint of therapeutic innovation. If granted, an accelerated review must be conducted within 150 days as opposed to the 210 days allowed for a standard technical assessment. 

References Reference number of Marketing and / or Manufacturing Authorisations EMEA reference number(s).(lf the inspection is an EMEA inspection). 

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