Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Vergleich der deutschen und Schweizer Vorgaben zur Erstellung der Fachinformation für Humanarzneimittel mit Fokus auf chemisch-synthetische Wirkstoffe ***

Dr. Stefanie Hirsch (Abschlußjahr: 2020)

Summary
Language: German
In this thesis, the specifications for the design of the German and Swiss Summary of Product characteristics (SmPC) are analyzed and compared in detail. Thereby, focus is on the content requirements for medicinal products with chemically synthetic active ingredients as well as formal design requirements with regard to the manuscript to be submit-ted to the competent authorities.
The aim is to highlight the similarities and essential differences and to discuss the implications derived from these for the text-responsible regulatory affairs manager on the company side, as well as for the healthcare professionals as addressees of the document.
It is shown that there are relevant differences in the extent and level of detail of the specifications, in the document structure, the sequence of information, as well as in the presentation of information for paediatric patients. In addition, contrary specifications and procedures are identified and information was detected which is to be listed in only one of the two SmPCs.
With regard to the healthcare professionals, the results allow the conclusion that, depend-ing on the country, a different approach must be used to obtain the same information in the respective document. The German SmPC, as a cross-linked document, is designed to guide the reader to full information of a specific aspect by using cross-references and duplicate entries. In contrast, in the Swiss SmPC focus is laid on the mention of each in-formation only once at a specific point in the document. The content of the individual sections is kept separate. This requires the user to have prior knowledge of the category under which the information sought can be found, in favor of a shorter document.
For the text-responsible regulatory affairs manager, the comparison of this work reveals the necessity of knowing the requirements of both countries in detail in order to efficiently navigate through the text assessment by the relevant competent authority. Although the guidelines are comparable in many respects, it is not possible to copy and paste the texts between the thematically corresponding sections of the German and Swiss SmPC. This applies both to the content level and to the stylistic means used, which in some cases are contrary between the two documents.
With regard to the history of the young nationwide Swiss pharmaceutical legislation, a gradual adaptation to the EU requirements seems to take place, but with the deliberate delimitation to maintain its own style.
Pages: 75