Germany: Food and Drugs Law

The EU Pharma Package introduces significant reforms to regulatory data and market protection periods for medicinal products, fundamentally altering the current "8+2(+1)" protection formula.

The EU Pharma Package introduces a novel approach to combat antimicrobial resistance through transferable exclusivity vouchers that reward innovation in priority antimicrobials while simultaneously implementing stricter antibiotic stewardship measures. This regulatory framework attempts to resolve the fundamental tension between incentivizing pharmaceutical companies to develop new antibiotics and ensuring these critical medicines are used prudently to prevent further resistance development.

From expanded approaches to scientific advice and a shift away from animal testing to new frameworks for platform technologies...

The regulatory frameworks in the life sciences and healthcare sector keep evolving rapidly and dynamically. Several important legislative reforms have been adopted...

On 16 December 2024, the Council of the European Union formally approved the new Packaging and Packaging Waste Regulation (PPWR), following its adoption by the European Parliament on 24 April 2024.

While it is getting cold outside, and everyone is preparing for the flu season of the year, the Commission is continuously and vigorously enforcing the bloc's competition law in the pharmaceutical sector.

Der Anwalt Ulrich Worm, Partner im Frankfurter Büro von Mayer Brown, bezweifelt, dass Zwangslizenzen zu mehr Dosen des Corona-Impfstoffes führen würden.

Das japanische Pharmaunternehmen Daiichi Sankyo hat sich erfolgreich gegen den frühzeitigen Markteintritt generischer Wettbewerbsprodukte zu seinem erfolgreichen Arzneimittel Sevikar® gewehrt.

The Japanese pharmaceutical company Daiichi Sankyo successfully defended itself against the early market entry of generic competitive products for its successful pharmaceutical product Sevikar®.