Japan has cautiously eased regulatory requirements related to novel drugs for rare diseases, with the Ministry of Health, Labour and Welfare (MHLW) to allow approval filings without data from Japanese clinical trials under certain conditions.
Japan Eases Local Clinical Data Requirements For Rare Disease Drug Filings
Japan is cautiously easing Japanese clinical data requirements for rare disease drugs to allow faster and more flexible approvals, including on a conditional basis supported by postmarketing studies.
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