European Medicines Agency - Centralized Marketing Authorizations and CHMP/CVMP

Centralized Marketing Authorizations and CHMP/CVMP

The centralized procedure allow companies to submit a single application to the Agency to obtain from the European Commission a centralized (or ‘Community’) marketing authorization (MA) valid in all EU and European Economic Area (EEA)-European Free Trade Association (EFTA) states (Iceland, Liechtenstein and Norway). The centralized procedure is compulsory for all medicines derived from biotechnology and other high-tech processes, as well as for human medicines for the treatment of HIV/AIDS, cancer, diabetes, neurodegenerative diseases, auto-immune and other immune dysfunctions, and viral diseases, and for veterinary medicines for use for growth or yield enhancers. The centralized procedure is also open to products that bring a significant therapeutic, scientific or technical innovation, or is in any other respect in the interest of patient or animal health. As a result, the majority of genuinely novel medicines are authorised through the EMA.

For products eligible for or requiring centralized approval, a company submits an application for a marketing authorisation to the EMA. A single evaluation is carried out through the Committee for Medicinal Products for Human Use (CHMP) or Committee for Medicinal Products for Veterinary Use (CVMP). If the relevant Committee concludes that the quality, safety and efficacy of the medicinal product is sufficiently proven, it adopts a positive opinion. This is sent to the European Commission to be transformed into a marketing authorisation valid for the whole of the EU. A special type of approval is the paediatric-use marketing authorisation (PUMA), which can be granted for medical products intended exclusively for paediatric use.

The CHMP and CVMP are obliged by the Regulation to reach decisions within 210 days, though the clock is stopped if it is necessary to ask the applicant for clarification or further supporting data. This compares well with the average of 500 days taken by the U.S. FDA.