Japan’s ruling coalition sustained a crushing blow in the Lower House election last month, only managing to win 215 seats,…
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REGULATORY
- MHLW Orders Updates from Chugai Following Criticism for Reporting Deficiencies by Roche in US
June 26, 2012
- MHLW Approves 11 Products Including Additional Indication for Lyrica
June 26, 2012
- Median Review Time Down by About Half Since FY2007: PMDA
June 25, 2012
- Antipyretic/Analgesics Are Most Common Cause for Relief Benefits for Damage from ADRs: PMDA
June 25, 2012
- PMDA Adopts New Rule for Staff Re-Employment Effective This Month, No Uses Made Yet
June 25, 2012
- 166 Applications Received for Preliminary Interviews for Regulatory Strategy Consultation in First 9 Months: PMDA
June 25, 2012
- Claims of “Ineffective” Generics Might Be Due to Placebo Effect in Some Cases: Mr Yoshida of HIB
June 25, 2012
- MHLW to Strengthen Focus on Dementia with Budget Request for FY2013
June 22, 2012
- MHLW to Draft New Guidelines on Pharmacotherapy for Dementia
June 22, 2012
- Nichi-Iko No. 1 in Terms of the Number of Generics Listed in June; Pfizer at 4th
June 22, 2012
- 60% Rule Applied for 3 APIs in June’s Generic Listing
June 22, 2012
- Access System for Unapproved Drugs to Be Submitted at Next Ordinary Diet Session “at the Latest”: Mr Kawai of DPJ
June 21, 2012
- MHLW Calls for OTC Switch for Hyaluronate Sodium
June 21, 2012
- Establishment of Third-Party Organization “Historical”: DPJ Member Kawai
June 20, 2012
- PMDA’s Science Committee Holds 1st Meeting; Will Work to Improve Review Quality through Exchanges with Researchers
June 20, 2012
- MHLW Committee Compiles Discussion Points on System for Public Release of Drug Damage Documents
June 20, 2012
- MHLW Withdraws Orphan Drug Designation for Somatropin
June 18, 2012
- MHLW Designates 5 Products, Including CLL Treatment, as Orphan Drugs
June 18, 2012
- DPJ Approves Draft Bill to Establish 3rd-Party Organization; Will Seek Discussions with Opposition
June 18, 2012
- Developed or Developing Countries: Which Side Is Right on Humanitarian Aid?
June 18, 2012
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For over two decades, Morunda has been at the forefront of interviewing and understanding leaders within Japan’s dynamic healthcare industry, particularly in pharmaceuticals and medical devices. What sets apart successful country managers in this competitive arena isn’t just their professional…
A Japanese health ministry panel discussing the generic industry structure on May 22 put together a report in which it…
A Japanese health ministry study group focused on pharmaceutical regulations on March 21 agreed on a policy to encourage the…
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…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…
The Japanese health ministry’s expert panel tasked to discuss comprehensive policies for the rapid and stable supply of pharmaceuticals generally…
A key Japanese reimbursement policy panel on December 16 approved the government-backed plan for the FY2023 “off-year” drug price revision.…
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…