Masterarbeit

CTD: Quality Overall Summary vs. Expert Report. Advantages and Disadvantages from the View of the Applicant and the Competent Authority

Lena M. S. Perquy (2002)

Summary

Throughout the life cycle of a drug product and due to technical changes and changed requirements, there are frequent document updates in the quality part of marketing authorisation documentation. Although considerable ground has been covered in the past decade towards harmonisation on the quality issue, national and / or ICH region specific quality documents are still required. In this context the CTD, the common format for marketing authorisation dossiers throughout the ICH regions, makes an approach towards harmonisation by giving the structure of the application a harmonised modular format that enables the applicant to file national or regional specific quality dossiers easily. Despite the ongoing discussions, a single appropriate filed quality dossier for different regions is not realistic at the moment, but it is possible to use several documents of the sections and subsections of the quality module for different regions.

The top-down review practice of the EU based Competent Authorities, relying upon trust and the interpretation of the data by the applicant, has created the need for and has defined the importance of the Expert Reports in the EU marketing authorisation processes. Due to this review approach, the experts' critical assessment of the quality documentation, has become a considerable tool in the decision making process of the Authority.

The EU defined Quality Expert Report has been adopted under the name Quality Overall Summary in the modular documentation system for the regions. For the Module 2.3 (which is the QOS) part of the region-wide CTD document, the ICH guideline has laid down the content of the document. Since the critical assessment of filed quality documents involves a lot of not harmonised elements, it is not clear whether all sections of a QOS will ever be compatible for different regions. And since the review praxis in the Agencies is not an issue for harmonisation, it is not clear, how the role of this harmonised document in the bottom-up-review environment of the FDA will develop.

In this thesis I have dealt with the characteristics, role and requirements of the Quality Expert Report as described in the Notice to Applicants and in comparison with the German Notes on MAA (1996). I have also considered the harmonisation process within marketing authorisation documentation and its impact on the quality documents. In addition I have compared the role of the Quality Expert Report with the role of the Quality Overall Summary and I have analysed the current and the future importance of the Quality Overall Summary together with the required guidance.

Pages: 38