It is particularly significant that the missing preparations include many with high medical benefits, including many with accelerated approval status. The findings are not surprising in one respect. The backlog is due less to rejections than to strategic decisions by companies. Many innovations are not even submitted for authorisation in Europe. As a result, the global dynamic is shifting further in favour of the USA, while China is also gaining in importance. Europe is becoming less attractive as an early market entry location. For Germany, this development is becoming a location issue. Companies are not only evaluating regulatory processes, but above all the economic framework conditions. Predictable reimbursement and reliable prospects determine whether innovations are available early or whether other markets are favoured. If this uncertainty increases, the trend threatens to intensify, with direct consequences for healthcare provision and the innovative strength of Germany as a healthcare location.
Press release of the "Verband Forschender Arzneimittelhersteller e.V." from 16.04.2026