The Drug development process - Pharmaceutical Biotechnology: Concepts and Aapplications

Biomedical Engineering Reference

In-Depth Information

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 specifi c 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 fi nished 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 informa-

tion is required; when this occurs, the 300-day 'clock' stops until the additional information is

received.

Pharmaceutical Biotechnology: Concepts and Aapplications

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