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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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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 accordance with the appropriate EU guidelines (Box 2.2). This appraisal must be completed within 10 days, at which time (if the application is in order), it is given a filing 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 2-3 days a month).
Two rapporteurs are then appointed (committee members who are responsible for getting the application assessed). The rapporteurs generally arrange to have the application assessed by their respective home national regulatory authority. Once assessment is complete, the reports are presented via the rapporteur 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 and ‘convert’ it into a decision (they — and not the EMEA directly — have the authority to issue a marketing authorization). The single marketing authorization covers the entire EU. Once granted it is valid for 5 years after which it must be renewed. The total time in which a decision must be taken is 300 days (210 + 90), which is
THE DRUG DEVELOPMENT PROCESS 87
Box 2.2. The marketing authorization application in the EU
The dossier submitted to EU authorities, when seeking a manufacturing authorization, must be compiled according to specific EU guidelines. It generally consists of four parts, as follows:
Part I (A) Administrative data
(B) Summary of product characteristics
(C) Expert reports
Part II (A) Composition of the product
(B) Method of product preparation
(C) Control of starting materials
(D) Control tests on intermediate products
(E) Control tests on finished product
(F) Stability tests
(Q) Bioavailability/bioequivalence and other information
Part III (A) Single dose toxicity
(B) Repeated dose toxicity
(C) Reproductive studies
(D) Mutagenicity studies
(E) Carcinogenicity studies
(F) Pharmacodynamics
(G) Pharmacokinetics
(H) Local tolerance
(Q) Additional information
Part IV (A) Clinical pharmacology
(B) Clinical trial results
(Q) Additional information
Part I (A) contains information which identifies the product, its pharmaceutical form and strength, route of administration and details of the manufacturer. The summary of product characteristics summarizes the qualitative and quantitative composition of the product, its pharmaceutical form, details of pre-clinical and clinical observations, as well as product particulars, such as a list of added excipients, storage conditions, shelf-life, etc. The expert reports contain written summaries of pharmaceutical, pre-clinical and clinical data.
Parts II, III and IV then make up the bulk of technical detail. They contain detailed breakdown of all aspects of product manufacture and control (Part II), pre-clinical data (Part III) and clinical results (Part IV).
88 BIOPHARMACEUTICALS
considerably shorter than the average approval times in many other world regions. The 300 day deadline only applies in situations where the CPMP do not require any additional information from the sponsor. In many cases, additional information is required and when this occurs, the 300 day ‘clock’ stops until the additional information is received.
Mutual recognition
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, 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.
If adopted by the national authority in question, the sponsor can seek marketing licences in other countries on that basis. For this bilateral phase, other states in which marketing authorization are sought have 60 days in which to review the application. The theory, of course, is that no substantive difficulty should arise at this stage, as all countries are working to the same set of standards as laid down in The Rules Governing Medicinal Products in the European Union.
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