Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Development of a regulatory toolbox for the approval procedure for medicinal products for human use ***

Dr. Gianna Thomsen (Abschlußjahr: 2024)

Summary
Language: English
The regulation of medicinal products for human use and their authorisation is very complex. The focus here is on maintaining and ensuring safety, efficacy and quality in the interests of patient welfare. Due to the dynamic developments in world affairs, such as globalisation, technical progress, demographic change or political instability, the healthcare sector is constantly faced with both familiar and new challenges at a global, sectoral and national level. Accordingly, the requirements for the regulation of medicinal products have become increasingly complex with the introduction of new technologies and therapeutic approaches and also due to changing healthcare needs. This constant development in turn requires continuous adaptation and dynamism in regulation in order to keep pace with the changes of the future and thus ensure patient safety and care.
These adjustments require measures that can be regarded as “regulatory elements”. The aim of this work is to identify possible regulatory elements for the approval procedure, using the framework conditions in Germany as an example, and to summarise these elements in a collection. On the basis of this collection, a regulatory toolbox is then developed. Methodologically, potential regulatory elements are first identified for the collection using four different approaches in order to obtain a broad spectrum of ideas from different perspectives. Challenges from industry stakeholders, ideas based on daily practice in a competent authority, the analysis of applied regulatory elements from several competent authorities as well as cross-sectoral ideas from the transfer of regulatory elements from industries and authorities outside the pharmaceutical sector are used. The potential regulatory elements obtained are then merged into a collection according to their content. The collection of regulatory elements recorded in this work contains a wide range of both very familiar as well as novel regulatory elements. Based on this collection, criteria and evaluation standards are determined on the basis of two defined scenarios and selected elements are summarised to form the respective regulatory toolbox. The approach used here to select elements for a toolbox reveals that criteria selection and evaluation are very sensitive steps in the creation of a toolbox. The selection of individual elements should therefore be based on a separate evaluation. For reasons of scope, this could not be carried out in the context of this work, so that individual results should initially be considered with reservations. The creation of a toolbox for a second scenario demonstrates the flexibility and adaptability of the method used here to develop a regulatory toolbox through its different results.
The concept of toolboxes is generally used in a wide range of industries. Accordingly, the insights and approaches gained here for the development of a regulatory toolbox demonstrate an interesting option for regulators. In general, the utilisation of a regulatory toolbox can be used as a helpful method to actively handle current or future regulatory challenges. The concept and development of a regulatory toolbox can also be applied regardless of country or project and therefore offers a versatile method for different contexts and requirements.
Pages: 86
Annexes: 4, Pages: 26 (excl. Acknowledgement and Affidavit)