How Do ICH Guidelines Affect Regulatory Submission and Approval?
The ICH guidelines also streamline the regulatory submission and approval process. For instance, the ICH M4 (Common Technical Document) provides a standardized format for submitting regulatory documents to multiple agencies, facilitating simultaneous reviews and approvals. This is particularly beneficial in cancer treatment approvals, where time is of the essence. The harmonization of submission requirements helps in reducing delays and bringing new treatments to market more efficiently.
