Marketing Authorisation Application

Marketing Authorisation Application (MAA) is a formal procedure that involves the submission of a dossier to a regulatory authority, such as the European Medicines Agency (EMA) or the Food and Drug Administration (FDA), to obtain approval for the marketing of a medicinal product. The MAA is a critical step in the drug development process and is required before a medicinal product can be sold in a particular jurisdiction.

Overview

The MAA contains detailed information about the medicinal product, including its pharmacology, toxicology, pharmacokinetics, and clinical trials data. The purpose of the MAA is to demonstrate that the medicinal product is safe, effective, and of high quality. The regulatory authority reviews the MAA and decides whether to grant a marketing authorisation (MA), which allows the medicinal product to be sold in the jurisdiction.

Process

The MAA process begins with the preparation of a dossier that contains all the necessary information about the medicinal product. This includes pre-clinical and clinical data, information on the manufacturing process, and proposed labeling and packaging. The dossier is submitted to the regulatory authority, which reviews the information and decides whether to grant the MA.

The MAA process can be complex and time-consuming, and it requires a thorough understanding of the regulatory requirements in the jurisdiction where the application is being made. It is often necessary to engage the services of a regulatory affairs professional to assist with the MAA process.

Regulatory Authorities

Different jurisdictions have different regulatory authorities that are responsible for reviewing MAAs. In the European Union, the EMA is the main regulatory authority, while in the United States, the FDA is responsible for reviewing MAAs. Other regulatory authorities include the Therapeutic Goods Administration (TGA) in Australia and the Health Canada in Canada.

See Also

• Drug development
• Clinical trials
• Pharmacology
• Toxicology
• Pharmacokinetics
• Regulatory affairs