The article addresses the question of who is responsible for granting marketing authorization for a medicine. It explains that this task is typically performed by a national competent authority, such as the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA). The article goes on to discuss the process by which marketing authorization is granted, and how it may be revoked if a medicine is found to be unsafe.
The marketing authorization holder
is the pharmaceutical company that has the right to market and sell the medicine in a particular country. The company must have obtained the authorization from the competent authorities in that country. In most cases, the marketing authorization holder is the pharmaceutical company that developed the medicine. However, sometimes another company may have obtained the marketing authorization through an agreement with the original developer.
The regulatory authority
The European Medicines Agency (EMA) is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union (EU). The Agency is also responsible for the safety monitoring of medicines after they have been authorised for use.
The EMA was set up in 1995 and is located in London, UK. The Agency is a decentralised body of the EU, with a scientific committee and a management board.
The scientific committee is responsible for the scientific evaluation of medicines, while the management board is responsible for the financial and administrative aspects of the Agency.
The EMA is funded by the EU member states and the pharmaceutical industry.
The marketing authorization procedure
The marketing authorization procedure is a process that allows a company to market a new medicine. The company must first submit an application to the competent authority, which will assess the medicine's safety, efficacy and quality. If the medicine is approved, the company will be issued a marketing authorization. The marketing authorization holder is responsible for ensuring that the medicine is used in accordance with the authorization and for monitoring its safety.