![]() Once granted by the European Commission, the centralised MA is valid in all EU Member States as well as in the following European Economic Area countries: Iceland, Liechtenstein and Norway [ The European Commission is the authorising body for all centrally authorised products, and it takes a legally binding decision based on EMA's recommendation. However, under EU law, EMA has no authority to permit marketing in the different EU countries. The Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) carries out a scientific assessment of the application and gives a recommendation on whether the medicine should be marketed or not. In the European Union (EU), access to new cancer drugs involves centralised licensing decisions by regulators and then each country decides on repayment according to its national healthcare systems. Access to cancer drugs, especially new innovative drugs, varies worldwide and depends on the country's economic strength and policy choices based on scientific evidence and cost-effectiveness. In addition, there are procedures for access to the medicinal products market before the marketing of the medicinal product is possible. The MA should guarantee the quality, efficacy and safety of the product. In the development of a drug, from the laboratory research phase to the end of clinical trials, it can take more than 10 years to obtain marketing authorisation (MA).
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