Pharmacy Courses

Contents of Marketing Authorization Dossiers

Marketing authorization dossiers are comprehensive documents submitted tatory authorities to obtain approval for the sale and distribution of a pharmaceutical product. Here's a simplified breakdown:

Title: Marketing Authorization Dossiers

I. Introduction

A. Purpose of the dossier

B. Overview of the product

C. Regulatory pathway

II. Quality Documentation

A. Pharmaceutical development

B. Manufacturing process

C. Specifications

D. Stability studies

III. Nonclinical Documentation

A. Pharmacology

B. Pharmacokinetics

C. Toxicology

IV. Clinical Documentation

A. Clinical pharmacology

B. Clinical efficacy

C. Clinical safety

D. Benefit-risk assessment

V. Regulatory Overview

A. Summary of product characteristics

B. Summary of labeling

C. Risk management plan

VI. Conclusion

A. Summary of key findings

B. Regulatory status

Each section provides crucial information supporting the safety, efficacy, and quality of the product, essential for regulatory approval.

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Resource Person: Diwakar Shukla
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