In this master’s thesis, we comparatively evaluate the regulatory requirements for obtaining a marketing authorisation for a medicinal product in the United States of America (USA), Canada, Australia, and the countries of the Eurasian Economic Union (EAEU). We also examine the key requirements and challenges for obtaining a marketing authorisation for a medicinal product in the European Union (EU). Regulatory requirements are key to ensuring the safety, efficacy, and quality of medicinal products. The aim of this assignment was to compare the regulatory frameworks in different countries and identify key differences and similarities, focusing on the challenges in the EU and approaches taken by other countries to address these issues.
We used a comparative analysis of data from official regulatory documents for the US, Canada, Australia, EAEU and the EU. The analysis was based on criteria such as the authorisation process, duration of procedures, safety and efficacy requirements, and specific programmes to speed up procedures. In the following section, we discuss in detail the regulatory requirements in selected countries. In the US, the process is led by the US Food and Drug Administration with strict requirements for clinical studies and fast-track programmes for innovative medicines. Canada has a similar system that allows for the fast-tracking of drugs with high therapeutic potential. Australia, through the Therapeutic Goods Administration, requires extensive evidence of safety and efficacy, and the EAEU is working towards harmonisation of procedures, but faces challenges in implementation.
The findings show that regulatory procedures in all regions are stringent and require extensive evidence on the safety and efficacy of medicines. However, procedures and durations vary, with the US and the EU standing out with their strict regulatory frameworks. We conclude that a comparative analysis of regulatory requirements provides valuable insights into the different approaches and challenges in obtaining marketing authorisations for medicines. The study highlights the need for further harmonisation to improve the efficiency of procedures and the accessibility of medicines on the markets and suggests further research in this area.
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