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
- PMDA to Conduct Pharmacokinetic Analysis in Pilot Study on Electronic NDA Submissions
April 1, 2014
- Lower House Panels to Begin Deliberations on Japanese NIH-Related Bills
April 1, 2014
- PMDA Announces Results of Pilot Study on Electronic NDA Submissions Using CDISC Standards
April 1, 2014
- Mixed Care to Be Boosted in Tokyo, Kansai Special Economic Zones: Panel
March 31, 2014
- Govt Deregulation Panel Pushes New System to Allow Mixed Care at Patient Request
March 31, 2014
- MHLW to Set Up Study Group on Clinical Research Legislation in April: Minister Tamura
March 31, 2014
- Science Council of Japan Recommends Establishment of Clinical Research Promotion Center at PMDA
March 31, 2014
- Fulminant Hepatitis Added to Precautions Section of Package Insert for Regorafenib: MHLW Safety Information
March 31, 2014
- MHLW Panel Concludes Novartis Systematically Involved in Diovan Trials: Report
March 28, 2014
- Drug-Induced Hypersensitivity Syndrome to Be Added to List of Clinically Significant Adverse Reactions for E Keppra: MHLW
March 28, 2014
- FY2014 Medical Fee Revision Expected to Shift Outpatient Care Functions from Large Hospitals to Smaller Hospitals and Clinics, Alter Patient Behavior and Prescription Patterns
March 28, 2014
- PMDA Floats New Advisory Service on Drug Makers’ Development Plans
March 27, 2014
- PMDA Announces Increase in Face-to-Face Consultation Fees in Response to Upcoming Hike in Consumption Tax
March 27, 2014
- PMDA Publishes RMP for Regpara
March 27, 2014
- Dr Tatsuya Kondo Reappointed as Chief Executive of PMDA
March 26, 2014
- MHLW Approves 37 Products, 4 New SGLT-2 Products OK’ed
March 25, 2014
- MHLW to Disclose Names of Wholesalers Abusing Penalty for Low Price-Settlement Rates
March 25, 2014
- Extra Market Drug Price Survey Focal Point of Discussions towards FY2015 Tax Hike: Official
March 20, 2014
- MHLW to Set Rules on OTC Switching of Diagnostics This Year
March 20, 2014
- MHLW to Draft Rules for Approval of Switch OTC Diagnostics in Meetings Open to the Public: Regulatory Reform Council
March 19, 2014
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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…