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REGULATORY
- MHLW Approves Hemlibra, Shingrix, Ozempic, and More
March 26, 2018
- 16 Possible Topics for New Guidelines Including Continuous Manufacturing to Be Discussed at First ICH “Interim Meeting” this Week
March 26, 2018
- Gilteritinib, 3 Other APIs Earn Orphan Designation
March 23, 2018
- MHLW to Purchase, Stockpile Enough Inavir for 3.81 Million People, Avigan for 1.91 Million People
March 23, 2018
- MHLW Orders Label Revisions for Samsca Acute Liver Failure Added to Significant ADR List
March 22, 2018
- Healthcare Experts at Odds over Nonprescription Switches of 3 PPIs
March 20, 2018
- Price Adjustments Based on Cost-Effective Assessments “Impossible”: Prof. Sakamaki
March 20, 2018
- MHLW to Discuss Creation of Post-Launch Premium for Add’l Indications: Official
March 20, 2018
- MHLW Health Policy Chief Questions Volume-Focused Sales Strategies, Urges Drug Makers to Shift to Healthy Lifespan Extension
March 19, 2018
- Lift Ban on Coadministration of Adrenalin Medications with Alpha-blocking Antipsychotic Drugs: MHLW Panel
March 19, 2018
- PMDA Estimates MID-NET Will Be Used for PMS for 18 Products Annually
March 16, 2018
- 3rd Batch of Sakigake Drugs to Be Announced Soon: MHLW Official
March 15, 2018
- MHLW Issues Safety Information with Special Feature on MID-NET Expected to Begin Full-Scale Operation on April 1
March 15, 2018
- PMDA’s Review Segment to Post Loss of around 500 Million Yen in FY2017; Ordinary Loss to Be Covered by Reserve Fund
March 14, 2018
- PMDA to Establish “Regulatory Science Center” in April to Deal with Advanced Science and Technology
March 14, 2018
- MHLW to Relax Regulatory Procedures to Prevent Discrepancies between Approved and Actual Manufacturing Practices
March 13, 2018
- Lexicon: G1/G2 Rule
March 9, 2018
- AMED Taking Applications for FY2018 CiCLE Grant Program, Will Make Final Selection by Early October
March 9, 2018
- Funding Disclosure Methods that Prohibit Printing Will Not Be Acceptable: MHLW Notifications on Clinical Research Law
March 9, 2018
- MHLW Proposes Working Group Discussions before Another Round of CEA Analyses for 7 Products: Chuikyo
March 8, 2018
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