Читать книгу Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) - William Gregory - Страница 103

All medicines must be authorized (=approved) before they can be marketed. There are two main ways for authorizing medicines: a centralized and a national one (that is, non-centralized).

Centralized Authorization Procedure (CAP): Pharmaceutical companies submit one single marketing-authorization application (MAA) to EMA. EMA’s Committee for Medicinal Products for Human Use (CHMP) then, using scientific resources provided by the Member States), carries out a scientific assessment of the application and makes a recommendation (an “opinion”) to the European Commission on whether the medicine should be marketed or not.

Once granted by the European Commission, the centralized MA is valid in all EU Member States as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway. The new or innovative medicines pass through the centralized authorization procedure in order to be marketed in the EU. This allows the marketing authorization holder (MAH) to market the medicine throughout the EEA on the basis of one single marketing authorization. The centralized process is required for certain medicines, e.g., biosimilars, gene therapies, etc.

National Authorization Procedures: The majority of medicines available in the EU were authorized at national level, either because they were authorized before EMA’s creation (1995) or they were not within the scope of the centralized procedure. Each EU Member State has its own national authorization procedures. If a company wishes to request an MA in several EU Member States for a medicine that is outside the scope of the centralized procedure, it may use one of the following routes:

Mutual Recognition Procedure (MRP), whereby a marketing authorization granted in one Member State can be recognized in other EU countries; or

Decentralized procedure, whereby a medicine that has not yet been authorized in the EU can be simultaneously authorized in several EU Member States.

Note: For issues that occur after authorization (e.g., safety concerns), the CHMP handles centrally-registered products. The Coordination Group for Mutual Recognition and Decentralized Procedures — human (CMD(h)) handles nationally-registered medicines and reports to the Heads of Medicines Agencies (HMA). The Pharmacovigilance Risk Assessment Committee (PRAC) (see below) is the senior committee that then handles all authorized products and makes recommendations to both CHMP and CMD(h).