Regulatory Guidelines For The Development Of Biologics In Us And Europe
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Abstract
In terms of the definition of a biologic and the technical specifications for approval, the United States and the European Union have different but overlapping regulatory frameworks for biologics. The term "biological product" has been used in the United States for a long time, and its understanding is still influenced by historical background. Biologics are primarily categorised in the European Union based on the components that make them up and the processes used to make them. Notwithstanding these differences, both jurisdictions agree that biologics require particular handling due to their unique qualities, such as their complicated structures and vulnerability to change during manufacturing. Biologics are subject to the general approval process in the EU as well as a few unique restrictions, in contrast to the US, where Congress passed a special statute for them. There is significant overlap in the standards imposed by both regions despite the fact that US and EU authorities have made steps to harmonise some technical requirements for biologics applications. An overview of the regulatory frameworks in the US and the EU is given in this chapter, covering everything from nonclinical trials to clinical trials and approval. The article then goes through approval and rejections in the us and Europe
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