Japan is considering a new approach to its “special” market expansion re-pricing that would exclude drug sales tied to private…
REGULATORY
MHLW to Draft GL on Use of Real World Data in Application Filings to Promote Development of Drugs for Rare Diseases
The Ministry of Health, Labor and Welfare (MHLW) plans to draft guidelines for using real world data in marketing authorization applications for ethical drugs. The guidelines will cover requirements for using real world data from national patient registries as control…
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REGULATORY
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