Regulatory Aspects of New Drug Development

There are many regulatory requirements for new drug development and approval. Before a sponsor submits a request for a drug to be registered for human use, a tremendous amount of highly specified laboratory testing, nonclinical work, and clinical trials need to be performed. In all cases, the procedures and results must be documented appropriately. From a regulatory perspective, if the research is not documented, for all intents and purposes, it has not been done. 

The new drug development and approval process includes several principal steps (RAPS, 2005)  

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