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
- PAFSC’s 1st Committee to Review 7 Products Including Bayer Yakuhin’s AMD Drug on Aug. 31
August 20, 2012
- Subcommittee on Refractory Diseases Prepares to Improve Medical Expenditure Subsidies: Interim Report
August 20, 2012
- PMDA Meets Targets for FY2011, but Measures Needed to Reduce Applicants’ Processing Time: MHLW’s Evaluation Council
August 20, 2012
- MHLW Designates 4 Products Including Thyroid Cancer Agent as Orphan Drugs
August 20, 2012
- US Regulation Could Delay Introduction of PBRER as ICH Standard
August 17, 2012
- 215 Preliminary Interviews Given for Regulatory Strategy Consultation in 1st Year: PMDA
August 17, 2012
- MHLW Approves Allegra Generics of 3 Companies for Listing in December
August 16, 2012
- MHLW Announces that Manufacturer’s Suggested Retail Prices of DPT-IPV Start at 6,500 Yen
August 15, 2012
- MHLW Approves Additional Indications for 8 Products Including AZ’s Symbicort
August 15, 2012
- Neo-Morgan Laboratory Developing a Variety of Organisms Using “Disparity Mutagenesis Technology”
August 14, 2012
- Drug Marketing Authorization Holders Submitted 36,641 Adverse Event Reports in FY2011: MHLW
August 14, 2012
- MHLW to Include Generic Drug Share Targets in Next 5-Year Medical Spending Optimization Plans in Response to Requests by Insurers
August 10, 2012
- MHLW Requires Revision of Package Inserts for 8 APIs including Oxaliplatin
August 9, 2012
- JPMA Calls for Maintenance and Expansion of R&D Tax Credit System at DPJ Hearings
August 9, 2012
- MHLW Study Group Takes Pass on Setting Up Relief System for Victims of Anticancer Drug Damage, Calling for Further Consideration by Government
August 8, 2012
- MOF Wants Generic Drug Share to Reach European, US Levels: Budget Examiner Shinkawa
August 8, 2012
- Talks between Health Minister, Plaintiff/Lawyer Groups Break Down on 3rd-Party Organization
August 7, 2012
- PAFSC’s First Committee Recommends Orphan Drug Designation for LAL Deficiency Treatment
August 7, 2012
- PAFSC’s First Committee Recommends Approval for Takeda’s Lotriga
August 7, 2012
- Health Minister Komiyama Continues Requesting IPV Price Cut
August 6, 2012
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