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REGULATORY
- Director Kamada of HPB’s Economic Affairs Division Calls for Cooperation in Promoting Distribution Reform
June 11, 2013
- Bill to Amend PAL Unlikely to Be Enacted in Current Diet Session
June 10, 2013
- MHLW to Establish “PMDA-WEST” in Kansai Region in October
June 10, 2013
- Council Announces “Comprehensive STI Strategy” to Create One Trillion Yen Market for Regenerative Medicine by 2030
June 10, 2013
- Japan Set to Perk Up R&D to Expand Drug Market to 9 Trillion Yen in 2020
June 7, 2013
- MHLW Asks Industry Organization to Take Steps to Ensure Proper COI Management in Response to Diovan Scandal: HPB Director-General at Diet
June 7, 2013
- Abe Vows to Lift Ban on Online OTC Drug Sales; MHLW to Form Panel to Verify Safety
June 6, 2013
- Novartis Pharma Taking Steps to “Clean Up Its Act” in Wake of Diovan Scandal: Minister of Health Tamura
June 5, 2013
- Study Group Fails to Reach Agreement on Online Sales of OTC Drugs; Final Report to Collate Different Views
June 4, 2013
- Provisional Measure Allowing Online Sales of Class 2 and 3 OTC Drugs to Be Extended to End of 2013: MHLW
June 4, 2013
- MHLW to Look into Correlations of Pediatric Drug Intakes and Adverse Reactions
June 3, 2013
- 14 APIs/26 Products Including Third Domestic Biosimilar Receive Listing
June 3, 2013
- FDA Approves World’s First MEK Inhibitor Discovered by JT
May 31, 2013
- Members of Study Group Say Ban on Use of Medical Information Database by Drug Makers Should Be Reconsidered After Trial Period Ends
May 31, 2013
- Expert Subcommittee to Begin Discussing Cost-Effective Assessments for Specific Medical Technologies
May 31, 2013
- H. pylori Eradication Could Greatly Reduce Medical Expenditure; Manufacturers of PPIs Will Need to Educate the Public
May 31, 2013
- Outline of Growth Strategy Embraces Japan-Version NIH, Promotion of Special System for Mixed Healthcare
May 30, 2013
- 45 Face-to-Face Consultation Meetings Provided through PMDA’s Regulatory Strategy Consultation Service as of March 2013
May 30, 2013
- MHLW Reprimands Novartis over Diovan Papers
May 29, 2013
- Report of MOF’s Fiscal System Council Calls for 100% Generic Share Target
May 29, 2013
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Earlier this month, Health Minister Keizo Takemi called on the top executives of 13 major generic makers to restructure the industry with a product consolidation target of “around five companies per API.” While a variety of restructuring options are conceivable,…
The Japanese health ministry on December 22 approved a batch of medicines for additional indications, including Otsuka Pharmaceutical’s atypical antipsychotic Rexulti (brexpiprazole) and Zenyaku Kogyo’s anti-CD20 antibody Rituxan (rituximab).Rexulti is now newly indicated for the treatment of depression and depressive…
Authorized generic (AG) strategies taken by innovative drug makers might help soften the impact of generic competition in their businesses but such tactics might also accelerate the application of “G1”/“G2” price cuts for their off-patent brand-name medicines, a Jiho tally…
Japan’s health ministry announced new NHI prices to be applied in April under the FY2022 drug price revision in the official gazette on March 4, with the earlier application of so-called “G1” price cuts to be implemented for the first…