Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Generic Drugs: eCTD module 3 differences and similarities between US and Europe with a special focus on IV-drugs

Dr. Abdelouahid El-Khattouti (Abschlußjahr: 2019)

Summary
Language: English
A medicinal product must be registered and authorized by the respective health authority before it can be placed on the market. Medicinal product registration is a stringent and complex process. The two major pharmaceutical markets in the world are the US and the EU, which have heavily regulated markets for medicinal products with regulatory requirements that vary to different degrees, but with the same goal of ensuring quality, safety and efficacy of the medicinal product for protecting human health. However, these differences create complications when a company plans to expand into new markets, and may delay medicinal products from reaching patients in need. The aim of this thesis is to draw special attention to the differences and similarities between the US and the EU marketing authorization application (MAA) requirements for generic intravenous medicinal products, especially with regard to Module 3.
Bringing a generic medicinal product on the market is a very complex process and non-harmonized requirements between the different regions poses an additional challenge. Harmonization of legal requirements for MAAs for the generic drugs is crucial for the pharmaceutical industry to be able to reduce workload and costs. The main driver of harmonization of those requirements is the ICH, and many ICH guidelines have been implemented to achieve this goal. A milestone was set with the harmonization of the technical requirements for a MAA by introducing the CTD, which provides a standardized structure (Module 2-5) for filing a MAA. This should make it possible to create a core MAA, which ideally can be submitted to the health authorities in all the ICH countries and in a few other countries.
Regardless, differences between the ICH regions still exist and need to be considered when preparing a MAA intended for both regions (EU and US) or adapting a MAA of one region to the other. Even though a harmonized CTD format for Module 2-5 has been developed and agreed on, some countries insist on keeping several pre-CTD MAA requirements. Historical differences, and the mindset and focus of the respective health authority is a determining factor for the expected data, the level of details and its presentation. The differences in the MAA are also the result of differences in the review process of the US and EU health authorities. While the FDA reviewers expect a comprehensive amount of raw data to evaluate and draw a complete picture, the EU reviewers expect an application which guides them through the critical aspects.
However, the different regulatory requirements and expectations of the various health authorities need to be considered. Therefore, as of now it is not possible to submit the same core MAA to the EU and the US health authorities. The knowledge of the regulatory requirements is therefore important to simplify the submission process and to set up a strategy.
Pages: 58