Masterarbeit

A review of regulatory drivers and anticipated changes to be adopted by 2025

Dr. Carina Tirler (2022)

Summary
Language: English
In recent years the pace of innovation has accelerated dramatically. The revision of the Orphan and Paediatrics Regulation, patient-focused drug development, DARWIN EU in conjunction with real-world evidence, the ICH guideline S12 on nonclinical biodistribution considerations for gene therapy products and the revision of the EU legislation on blood, tissue and cells are important regulatory drivers shaping the regulatory environment in the EU up to 2025. This thesis contains a brief summary of the development priorities, an overview about the current status and a comparison between the developments in the EU and the USA. The comparison with the USA has shown that developments in the EU have lagged behind many developments in the USA. The USA is still a pioneer, for example in the area of patient-focused drug development, where in comparison to the EU, the USA have already specific guidelines. At least in terms of real-world evidence, the EU seems to be on a similar level to the USA. Additionally, in this thesis the development priorities have been considered in conjunction with the EMA regulatory science strategy. It was established that all development priorities except for the revision of the blood, tissue and cell regulation can be found in the regulatory science strategy. Furthermore, the implementation of the regulatory science strategy was checked on the basis of news on the EMA website. It was found that most developments are already being implemented since the regulatory science strategy was announced. Moreover, hypotheses beyond the year 2025 are put forward, which are mainly based on IMI projects and on new developments in the USA. These focus on technological developments, including artificial intelligence, and the development of new drugs.
Pages: 54
Annexes: 6, Pages: 24