GERMANY Trends and Developments Contributed by: Ulrich Grau, Constanze Püschel and Tobias Volkwein, D+B Lawyers
of 18 November 2025, the G-BA adapted its rules of procedure accordingly. The first Joint Clinical Assess- ment Report is expected to be published in summer 2026. Challenges in clinical trials and regulatory simplification In terms of clinical trials, the implementation of the Clinical Trials Regulation (Regulation (EU) No 536/2014; CTR) and the Clinical Trials Information System (CTIS), in particular, is still causing many prac- tical issues for the industry. However, the legislator has taken a first step to improving the legislative con- ditions to conducting clinical studies in Germany. With the MFG, simplifications of the regulatory framework for clinical studies were introduced, eg, the facilitation of the regulatory process for clinical studies affecting the Radiation Protection Law or the shortening of the processing time for the authorisation of mono-national clinical trials with medicinal products. Furthermore, the concept of common standard contractual clauses for clinical trial agreements was introduced into law for the first time. The respective Ordinance on Standard Contractual Clauses for the Conduct of Clinical Tri- als applies to contracts concluded after 17 December 2025. Anticipating the EU pharmaceutical law package The “next big thing” for pharmaceutical entrepreneurs at a European level, beyond the further legislative pro- gress of the European Health Data Space Regulation (EHDS), clearly lies in the new EU pharmaceutical law package. On 26 April 2023, the EC presented the fol- lowing legislative proposals aimed at revising the EU medicinal products legislation: • first, a proposal for a Directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use; and • second, a proposal for a Regulation of the Europe- an Parliament and of the Council laying down EU procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency.
The proposals intend to repeal several pieces of EU legislation, including Directive 2001/83/EC and Regulation (EC) 726/2004. This revision is part of the implementation of the Pharmaceutical Strategy for Europe and aims to promote innovation while reduc- ing the regulatory burden and environmental impact of medicinal products. This will undoubtedly have a huge impact on the phar- maceutical industry in Germany, and the proposals have already been widely debated. Unsurprisingly, the respective drafts from the Commission and Par- liament (2024) differ in their provision of regulatory data protection. In June 2025, the Council agreed its position and the trilogue negotiations subsequently commenced. In the trilogue of 11 December 2025, a preliminary political agreement was reached, the texts of which were published on 6 March 2026. Challenges for medical device manufacturers under the Medical Devices Regulation Manufacturers of medical devices still face the chal- lenge of adapting to the Medical Devices Regula- tion (MDR), which sets the regulatory framework for the marketability of their products. This demands an understanding of the new legal requirements and the implications for the certification process and the design of quality management systems. The German industry was also relieved by the news that, after months of discussions, the transitional pro- visions of the MDR were extended. However, even with more time, the preparation for stricter regulations remains challenging for the industry, with many ques- tions still unanswered. Accordingly, new proposals for further practical facilitation measures have already been submitted.
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