Marketing Authorisation Application (MAA) is an application submitted by a drug manufacturer seeking
marketing authorisation, that is permission to bring a
medicinal product (for example, a new medicine or generic medicine) to the market.
MAA is part of the official procedure before the
Medicines and Healthcare products Regulatory Agency
The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably ...
in the
United Kingdom and the
Committee for Medicinal Products for Human Use of the
European Medicines Agency
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of medicinal products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or Euro ...
, a specialised agency of the
European Commission. In the
United States, the equivalent process is called
New Drug Application.
References
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Drug safety