Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Application for Marketing Authorisation for a Generic Medicinal Product in Germany and Canada - Comparative presentation of content in Module 3 considering the country specific Regulatory Requirements

Kristina Baitinger (Abschlußjahr: 2019)

Summary
Language: English
The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was founded in 1990 with the goal of a harmonized standard for applications and their assessment criteria. The ICH was established by the Federal Drug Association (FDA), the European Commission and the Japanese Ministry of Health, Labour and Welfare (MHLW) as well as the industry associations of USA, Europe and Japan. To achieve this goal, many ICH guidelines have been implemented since then, for example concerning quality and safety of pharmaceutical products, preclinical and clinical requirements as well medical terminology. Another important establishment was the introduction of a standard for the structure of a dossier for a pharmaceutical product, the Common Technical Document (CTD).
This internationally harmonized format for the presentation of applications through unified guidelines should make it possible to create a dossier for drug application, which can be submitted to authorities in all three ICH regions.
Canada is a standing regulatory member of the ICH, whereas the World Health Organization (WHO) and European Free Trade Association (EFTA) have the status of an observer.
Therefore a dossier for a generic drug application shall be submitted in the form of a CTD in Canada as well as in the ICH regions as Germany. In Germany, generic drugs are approved under Marketing Authorisation Application (MAA) and in Canada under Abbreviated New Drug Submission (ANDS).
The regulatory requirements and national particularities vary from country to country. Therefore it’s difficult to submit only one identical dossier in different countries despite harmonization. The knowledge of the regulatory requirements is therefore important to simplify the submission process and to set up a strategy.
The objective of this Master Thesis is to compare the CTD Module 3 Quality with regard to content and presentation of data has to be submitted for Drug Substance and Drug Product shortly and to point out the main differences in the national requirements between Germany and Canada.
The comparison of the content of Module 3 in Germany and Canada will be mainly done according to the Notice to Applicants Volume 2B - Presentation and format of the dossier for Germany and according to the Guidance Document - Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs) for Canada.
The main differences in content and presentation of data will be described in detail and the results will be compared in tabular form.   
Pages: 62