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REGULATORY
- PMDA’s Regulatory Consultation Service Off to Good Start, but More Effort Needed to Promote Face-to-Face Advisory Meetings: Dr Isobe
August 22, 2012
- Healthcare to Receive Priority in FY2013 Draft Budget Request Guidelines
August 21, 2012
- 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
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In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…
