Marketing authorisation

Marketing authorisation is a legal status that allows the commercial distribution and sale of a pharmaceutical product within a specified jurisdiction. It is granted by a regulatory authority after a thorough evaluation of the product's safety, efficacy, and quality.

Overview

Marketing authorisation is a critical step in the drug development process. It is the final stage before a new medicine can be introduced to the market. The process involves a comprehensive review of the clinical trial data, manufacturing process, and labelling of the product.

Process

The process for obtaining marketing authorisation varies by jurisdiction. In the European Union, the European Medicines Agency (EMA) is responsible for the centralised procedure. In the United States, the Food and Drug Administration (FDA) grants marketing authorisation.

Application

The applicant, usually a pharmaceutical company, submits a dossier containing all relevant information about the product. This includes results from preclinical studies, clinical trials, information on manufacturing, and proposed labelling and package inserts.

Review

The regulatory authority reviews the application to determine whether the product meets the necessary standards of safety, efficacy, and quality. This review process can take several months to years, depending on the complexity of the product and the completeness of the application.

Decision

If the regulatory authority determines that the benefits of the product outweigh its risks, it grants marketing authorisation. This allows the product to be sold and marketed within the jurisdiction.

Post-authorisation activities

After a product has received marketing authorisation, the manufacturer is required to conduct post-marketing surveillance to monitor the product's safety and efficacy in the general population. This includes reporting any adverse events and conducting post-marketing studies if necessary.

See also

• Drug development
• Regulatory affairs
• Pharmaceutical industry