ABSTRACT
In Europe, regulatory decisions concerning approval of drugs are made centralized by the European Medicines Agency (EMA), while reimbursement decisions are made decentralised at the national level by all member states. Historically access to new drugs was dependent on the regulatory approval, but in recent years this has shifted towards reimbursement being the restricting factor. Main drivers of this development are the ever increasing costs of new drugs, the decline in quality and robustness of submitted data, and the increasing pressure to accelerate drug approval and reimbursement processes.
