A Marketing Authorization Application (MAA) is a comprehensive dossier submitted by a pharmaceutical company to regulatory authorities to obtain approval to market a new drug or biologic. It includes detailed information on the drug's safety, efficacy, quality, and manufacturing process, and is a critical step in bringing a new treatment to market in regions like the European Union.

Marketing Authorization Application

Comprehensive dossier

Pharmaceutical company

Regulatory authorities

Approval to market

New drug

Biologic

Detailed Information

Drug's safety

Drug's efficacy

Drug's quality

The manufacturing process is a series of steps that transforms raw materials into finished products through various techniques and operations. It involves planning, designing, and controlling the production process to ensure efficiency, quality, and cost-effectiveness.

Manufacturing Process

Critical Step

New treatment

The European Union (EU) is a political and economic union of member countries located primarily in Europe, aimed at fostering economic cooperation and ensuring peace and stability across the continent. It operates through a hybrid system of supranational and intergovernmental decision-making, with its own institutions, legal framework, and currency, the euro, used by 19 of its member states.

European Union

Concepts

Relevant Degrees

Your Lessons