A regulatory dossier (German translation: Zulassungsdossier) is a collection of documents that a pharmaceutical company compiles for submission to national or international regulatory authorities for the marketing authorization of a drug. It contains a detailed description of all aspects relating to the development, manufacture, safety (German translation: Unbedenklichkeit) and efficacy (German: Wirksamkeit) of the drug. A regulatory dossier is the basis for assessing the conformity of a drug with safety, quality and efficacy requirements before it is placed on the market.

A regulatory dossier consists of the following:

• General information about the drug (British English: medicinal product): Name of the drug, dosage form, dosage, areas of application, storage conditions.
• Application documents: This includes the application for marketing authorization, information about the manufacturer and distributor, certificates, drug, instructions for use (German translation: Gebrauchsinformation) and a price recommendation.
• Chemical and pharmaceutical data: Information on the composition, physico-chemical, biological and microbiological properties of active pharmaceutical ingredients and excipients and certificates for active pharmaceutical ingredients.
• Information on drug manufacture: Process flow diagram, in-process controls and control of intermediates (German translation: Zwischenprodukte), process validation and system qualification.
• Information on the quality control of the drug: Methods for quality control of the drug, analytical procedures, validation of analytical procedures, batch analysis and stability test results.
• Preclinical studies: Data from laboratory and animal studies confirming the safety and preliminary efficacy of the drug.
• Clinical studies: Results of human trials confirming the therapeutic efficacy, optimal dosage and safety of the drug.
• Packaging and labeling documents: Description of the packaging and the instructions for use as well as proof of the safety of the packaging materials.

Purpose of the regulatory dossier:

The regulatory dossier provides the regulatory authorities (German: Aufsichtsbehörden) with comprehensive information that allows them to evaluate the drug. The regulatory dossier is the basis for the decision on whether market authorization, which allows the manufacture of the drug and its market release, will be granted. The regulatory dossier ensures that a drug meets the requirements for safety, quality and efficacy.

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