The centralized procedure

Under the centralized procedure, applications are accepted with regard to (a) products of biotechnology; (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 considered 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 accordance 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 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 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

Box 4.4

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

Part I (B)

Summary of product characteristics

Part I (C)

Expert reports

Part II (A)

Composition of the product

Part II (B)

Method of product preparation

Part II (C)

Control of starting materials

Part II (D)

Control tests on intermediate products

Part II (E)

Control tests on finished product

Part II (F)

Stability tests

Part II (Q)

Bioavailability/bioequivalence and other information

Part III (A)

Single-dose toxicity

Part III (B)

Repeated-dose toxicity

Part III (C)

Reproductive studies

Part III (D)

Mutagenicity studies

Part III (E)

Carcinogenicity studies

Part III (F)

Pharmacodynamics

Part III (G)

Pharmacokinetics

Part III (H)

Local tolerance

Part III (Q)

Additional information

Part IV (A)

Clinical pharmacology

Part IV (B)

Clinical trial results

Part IV (Q)

Additional information

Part I (A) contains information that 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 preclinical 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, preclinical and clinical

data.

Parts II, III and IV then make up the bulk of technical detail. They contain detailed break

downs of all aspects of product manufacture and control (section II), preclinical data (section

III) and clinical results (section IV).

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). 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; when this occurs, the 300-day 'clock' stops until the additional information is received.

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