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Busting the billion-dollar myth: how to slash the cost of drug development

When an applicant applies for a GMP inspection to obtain marketing approval or approval to make partial changes to the approved information (hereinafter referred to as “partial change approval”) for a drug (excluding drugs that are drug substances), quasi-drug, or medical device (hereinafter referred to as “drugs etc.”), or to manufacture drugs for export etc., the applicant shall, in principle, submit an application for a GMP inspection for each relevant product. As a rule, the application for a GMP inspection must be submitted to an inspection entity that will conduct the GMP inspection (hereinafter referred to as “competent inspection authority”) for all manufacturing sites and other relevant sites indicated in the product approval application (including manufacturing sites of drug substances, manufacturing sites for packaging, external testing laboratories, and organizations that perform design and development control

[hereinafter referred to as “design and development control”]

; the same shall apply hereinafter).