Masterarbeit
Extensions of indication in the European Union - a regulatory overview ***
Silvia Balogh (2016)
Summary
Language: English
The extension of an initially approved indication is one of the principal methods used to extend the lifecycle of a medicinal product (MP) in the post authorisation phase. However, the regulatory background of extensions of indications is complex, and no over-arching guideline exists for the European Union. This thesis shows the different criteria upon which extensions of indications can be based and provides an overview of the regulatory strategies used to introduce a new indication, covering their relevance and timing, as well as possible incentives. The thesis quantifies the relevance and timing of the introduction of extensions of indications via applications for Type II variations, line extensions and new marketing authorisations, and the relevance of incentives. For this purpose, the European public assessment reports (EPARs) of 726 currently centrally authorised innovator MPs for human use are examined. In addition, the thesis presents the regulatory assessment and dossier requirements for Type II variations to extend indications. Finally, this thesis provides orientation on the access of reimbursable MPs with extended indications to the German market. In order to establish practical relevance of the different topics for regulatory affairs employees, various examples are given in the different chapters.
Pages: 59
Annex: 14 Tables (26 pages)