Discussions by the Ministry of Health, Labor and Welfare’s (MHLW) study group on the generic industry structure are reaching the last lap. Its final report - a draft of which will be presented later this month - is expected to…
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REGULATORY
- MHLW Panel to Kick Off Debates on Amendment of Pharmaceuticals and Medical Devices Law
April 5, 2018
- PMDA Announces Report Outlining “Current Views” on Introduction of Continuous Manufacturing
April 5, 2018
- Ono Takes over Orphan Designation for 2 Products Including MEK Inhibitor from Array BioPharma
April 4, 2018
- MHLW to Discuss Stockpiling of Xofluza, Tamiflu Generics in FY2018
April 3, 2018
- Use of Big Data Entering New Stage with Launch of MID-NET, Enforcement of New Law
April 3, 2018
- AMED Out-Licenses 2 Compounds in Drug Discovery Support Initiative
April 2, 2018
- Chuikyo Begins Debate on Sales Tax Hike, Agrees on Drug Price Survey in 2018
April 2, 2018
- MHLW Orders Package Insert Revisions for Antibacterial Drugs
March 29, 2018
- Sakigake Status Goes to World’s 1st Renal-Function Improving Agent, BBB-Penetrating Hunter Syndrome Med and 4 More Drugs
March 28, 2018
- MHLW’s Panel to Discuss First Revision of Anti-RA Measures in 7 Years; Proper Use of Biologics to Be a Focus
March 28, 2018
- Council OKs Public Knowledge-Based Application for Elplat Triplet
March 26, 2018
- 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
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