Regulatory Considerations

Across the globe, numerous regulatory bodies are responsible for assuring safety, quality, and efficacy of medicinal products. Significant progress has been made over the years toward harmonization of requirements for regulatory filings through the work of the International Council on Harmonization (ICH). This work is continuing, and there is also an ongoing paradigm shift in the US FDA concerning CMC regulatory packages and agency reviews. The CMC regulatory paradigm is evolving into a system emphasizing the establishment of fundamental understanding of product critical quality attributes, which are those critical aspects of the drug product that impact the performance in the patient and may be influenced by robustness of the manufacturing process. The new process acknowledges that the concept of product quality must be based upon clinical relevance, and the previous discussion has highlighted the relevance of biopharmaceutics to clinical performance. Importantly, the biopharmaceutics knowledge base contributes to the establishment of a product's "design space," reflecting the ranges of multiple, interrelated material properties and manufacturing parameters within which acceptable product performance is assured with a high degree of confidence.

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