Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Worksharing procedure - what’s the point? An overview about worksharing procedure as regulatory tool

Katarzyna Makosch (Abschlußjahr: 2021)

Summary
Language: English
The pharmaceutical industry is a highly regulated environment, where in near to all countries worldwide the marketing of medicinal products is only possible with an approval from the responsible health authority. As the medicinal product undergoes several changes to the initially approved documentation during their life cycle, these changes need to be submitted to the relevant national authority for information and/or approval to ensure the quality, safety and efficacy of the medicinal product. In the European regulatory system consists of a combination of national, centralised and decentralised Marketing Authorisation, to provide access to high-quality and safe medicinal products across the European Union. For life cycle management of the different marketing authorisation types a very useful tool was developed. It allows Marketing Authorisation Holders to gain a harmonised dossier regarding submitted identical variations for several products in several member states of European Union. This tool, named worksharing procedure saves also the resources of national competent authorities and, in addition to harmonised documentation for the medicinal product, leads therefore to its increased safety and quality through easier life cycle management for harmonised dossier.
As this procedure is still relatively new in the regulatory landscape, it is still not used as often as may be possible. Therefore, this thesis elaborates the answer why the worksharing procedure is still not used in all theoretically possible cases. A special focus is set on possibility for harmonisation of Summary of Product Characteristics (SmPC), as a quintessence of whole documentation included in the dossier of medicinal product.
As worksharing is still not very common for submission of identical variations for several marketing authorisations in different member states of the European Union, this thesis includes description of most common cases for worksharing procedure and steps needed to be performed before and during the submission of variation(s) within this procedure.
To explore and answer the question about the willingness to use the worksharing procedure in the pharmaceutical industry, a survey was prepared and sent to regulatory managers from different pharmaceutical companies. In this way, practical experiences with the worksharing procedure directly from industry and from persons involved is integrated into this work. The evaluation of these results gives an overview about the advantages and disadvantages of the worksharing procedure from the point of view of pharmaceutical industry and marketing authorisation holders. It was also possible to identify the most important reasons for using or not using of worksharing as a submission tool. In conclusion possible solutions to increase the acceptance of this procedure are suggested.
Pages:  52