A Marketing Authorisation Application (MAA) provides comprehensive information about a medicinal product, enabling regulatory authorities to assess its quality, safety and efficacy, and to evaluate the ability of the future Marketing Authorisation Holder (MAH) to ensure and monitor a sustainable risk-benefit balance.
The MAA is the most important part of placing a medicine on the market. Failure to submit a compliant MAA can have undesirable consequences.
Starting from the legal framework, you will learn about the EU, US and UK procedures for obtaining marketing authorizations for pharmaceutical products, the documentation required in support of an application, with a brief introduction to the clinical studies which may support an application. You will become aware of the different types of medicinal products such as generics, originators, orphan drugs and pediatrics, and what are the differences in terms of documentation to be presented.
Focusing on the EU, we will analyze the pre-submission steps as well as the post-submission steps needed to not lose track of the timelines, which are necessary to plan the successful entry of your product in the market.
About UK and US, the must and the main differences with the EU steps will be analysed.