Biomedical Engineering Reference
In-Depth Information
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The Committee for Medicinal Products for Veterinary use (CVMP), whose structure and role is
similar to the CPMP, except that it is concerned with animal medicines.
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The Committee for Orphan Medicinal Products (COMP), composed of a representative from
each EU member state and EMEA and patient representatives. The COMP assesses applications
relating to experimental medicines being granted 'orphan' status. Orphan medicines are those
intended to treat rare diseases, and orphan designation results in a reduction of the fees charged
by the EMEA when assessing marketing authorization applications.
Unlike the FDA, the EMEA itself does not directly undertake appraisals of drug dossiers sub-
mitted 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 ap-
plication 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:
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protection of public and animal health by ensuring the quality, safety and effi cacy of medicinal
products for human and veterinary use;
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to strengthen the ideal of a single European market for human and veterinary pharmaceuticals;
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to support the European pharmaceutical industry as part of the EU industrial policy.
4.14.7 The centralized procedure
Under the centralized procedure, applications are accepted with regard to (a) products of biotech-
nology; (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 con-
sidered 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 accord-
ance 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 fi ling 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).
Two rappoteurs are then appointed (committee members who are responsible for getting the
application assessed). The rappoteurs generally arrange to have the application assessed by their
respective home national regulatory authorities. Once assessment is complete, the reports are
presented via the rappoteur to the CPMP. After discussion, the CPMP issue an 'opinion' (i.e. a
recommendation that the application be accepted, or not). This opinion is then forwarded to the
European Commission, who have another 90 days to consider it. They usually accept the opinion
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