Marketing authorisation

A marketing authorisation (MA) is a legal licence that a pharmaceutical developer must obtain from a national or regional regulatory body before it can sell and distribute a medicinal product. This authorisation confirms that the medicine has been rigorously assessed and meets the necessary standards for quality, safety, and efficacy for its intended use.

The application for an MA, known as a marketing authorisation application (MAA), requires the company to submit a comprehensive dossier of evidence from all stages of the drug development process, including:

• Quality data: Information on how the product is manufactured and controlled.
• Non-clinical data: Results from laboratory and animal testing.
• Clinical data: Evidence from human clinical trials demonstrating the medicine’s safety and effectiveness.

In the UK, the regulatory body is the Medicines and Healthcare products Regulatory Agency (MHRA). In the European Union, a single centralised authorisation can be granted by the European Medicines Agency (EMA) that is valid across all Member States. The granting of an MA defines the specific conditions for a medicine’s use, including its approved indications, dosage, and patient groups.