PHARMA JAPAN welcomes JETRO New York’s Shunsuke Tani as a guest columnist. In occasional contributions, Tani will share his perspectives on US pharmaceutical policy, industry developments, and life in America, drawing on his firsthand experience in the US.---Hello from New…
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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