Masterarbeit

Regulatory challenges for the registration of generic transdermal patches - A Guidance for Regulatory Affairs

Dr. Janinne Sylvie Schmid (2012)

Language: English

The aim of this thesis is to provide guidance for peers in Regulatory Affairs on how to register a generic transdermal patch.

In this thesis the main steps from development to registration of transdermal patches are discussed and the unique features of this pharmaceutical form are highlighted. Furthermore, the impact of development, bioequivalence studies, patents and manufacturing on Regulatory Affairs as well as the requirements for these departments given by Regulatory Affairs are identified.

There is a particular focus on the guidelines available and on recent changes in these. Several guidelines have been or soon will be updated in order to keep up with the progress in this field. Poorly or unregulated topics therein are addressed.

Finally, a in parts preliminary outline on the most important points to consider with regard to the registration of a generic transdermal patch is provided and typical bottlenecks are indicated.

Pages: 42