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biopharmaceuticals biochemistry and biotecnology - Walsh G.

Walsh G. biopharmaceuticals biochemistry and biotecnology - John Wiley & Sons, 2003. - 572 p.
ISBN 0-470-84327-6
Download (direct link): biochemistryandbiotechnology2003.pdf
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Table 2.14. The nine-volume series that comprises The Rules Governing Medicinal Products in the European Union
This entire legislation has been published in the form of a nine-volume series entitled The Rules Governing Medicinal Products in the European Union (Table 2.14). These volumes form the basis of EU-wide regulation of virtually every aspect of pharmaceutical activity.
The EMEA and the new EU drug approval systems
In 1993, a significant advance was made in simplifying the procedures relating to drug marketing authorization applications in the EU. At that time, the legal basis of a new drug approval system was formed by an EU regulation and three directives. Central to this was the establishment of the European Medicines Evaluation Agency (EMEA), which is based in London and began work in January 1995. Two new marketing authorization (drug registration) procedures for human or veterinary drugs are now in place within the EU:
• a centralized procedure in which applications for a marketing licence are forwarded directly to the EMEA;
• a decentralized procedure based upon mutual acceptance or recognition of national authority decisions. Disputes arising from this system are arbitrated by the EMEA.
The EMEA comprises:
• a management board, consisting of representatives of each EU member state as well as representatives of the European Commission and European Parliament. This group functions mainly to coordinate EMEA activities and manage its budget;
• pre-authorization evaluation of medicines for human use unit. This unit provides scientific advice relating to quality, safety and efficacy issues, as well as relating to orphan drugs;
• post-authorization evaluation of medicines for human use. This regulatory affairs unit is responsible for issues such as post-marketing surveillance of drugs;
• veterinary medicines and inspections. This unit is responsible for veterinary marketing authorization procedures as well as inspections.
Central to the functioning of the EMEA are three committees:
• the Committee for Proprietary Medicinal Products (CPMP). 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;
1, Pharmaceutical Legislation
2, Notice to Applicants
3, Guidelines
4, Good Manufacturing Practices
5, Pharmaceutical Legislation
6, Notice to Applicants
7, Guidelines
8, Maximum residue limits
9, Pharmacovigilance
Medicinal products for human use
Medicinal products for human use
Medicinal products for human use
Medicinal products for human and veterinary use
Veterinary medicinal products
Veterinary medicinal products
Veterinary medicinal products
Veterinary medicinal products
Medicinal products for human and veterinary use
• the Committee for Veterinary Medicinal Products (CVMP), whose structure and role is similar to the CPMP except that it is concerned with animal medicines;
• the Committee for Orphan Medicinal Products (COMP), composed of a representative from each EU member state, as well as 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 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 ˆ70 million. The key objectives of the EMEA may be summarized as:
• protection of public and animal health by ensuring the quality, safety and efficacy of medicinal products for human and veterinary use;
• to strengthen the ideal of a single European market for human and veterinary
• to support the European pharmaceutical industry as part of the EU industrial policy.
The centralized procedure
Under the centralized procedure, applications are accepted with regard to (a) products of biotechnology; (b) new chemical entities (NCEs: drugs in which the active ingredient is new). Biotech products are grouped as ‘list A’, 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.
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