Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
PMDA Eyes Mandatory Electronic Filings for NDA Clinical Trial Data from FY2016
The Pharmaceuticals and Medical Devices Agency (PMDA) intends to require drug makers to submit clinical trial data for their new drug applications (NDAs) in electronic formats, beginning in FY2016—a move that would allow the authority to efficiently store and analyze…
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REGULATORY
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Japan is ramping up its push to spread regional formularies nationwide, a policy expected to standardize treatments, strengthen supply resilience,…
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Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…