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 to Lift Ban on Subcontracting of Safety Management Tasks in November
August 15, 2014
- Health Ministry Notifies Prefectures of New Regulatory Service Fees
August 14, 2014
- First Meeting of PMDA’s Panel on Placebo-Controlled Studies Set in Early October
August 13, 2014
- PMDA Will Prosper by Promoting Review Work, Research, and Training Together: Chief Executive
August 13, 2014
- Health, Science Ministries Solicit Public Comments on New Clinical Research Ethics Guidelines
August 12, 2014
- Editor’s Pick: Five Healthcare News Headlines for July 28 - August 8
August 11, 2014
- PAFSC Second Committee Supports Approval of G-CSF Drug Pegfilgrastim
August 11, 2014
- Upcoming Act on Pharmaceuticals and Medical Devices to Require “Latest Information in Package Inserts”: PFSB
August 11, 2014
- MHLW Orders Revision of Package Insert for Remicade
August 8, 2014
- Is Legal Regulation Necessary? Clinical Research at Turning Point 3: Dr Yamamoto of SCJ
August 8, 2014
- Govt to Enhance Support to Boost Pharma Sector’s Competitiveness: Health Policy Bureau Head
August 7, 2014
- Health Insurance Bureau Chief Says Discussions on Accurate Market Prices and Frequency of NHI Price Revisions Important
August 7, 2014
- MHLW Issues Notification Calling for Compliance with GVP Ministerial Ordinance
August 7, 2014
- MHLW to Survey Rate of Generic Drug Use Under High-Cost Healthcare System; Regulatory Reform Council Concerned that System Provides Little Incentive to Use Generics
August 6, 2014
- PFSB’s Budget Request for FY2015 Will Seek Funding to Strengthen Operations at PMDA: Director-General
August 6, 2014
- MHLW to Remind Drug Makers of Proper ADR Reporting in Wake of Administrative Improvement Order to Novartis
August 4, 2014
- MHLW to Fund Research Aimed at Obtaining Additional Indications for Intractable and Orphan Diseases for Existing Drugs
August 4, 2014
- PAFSC First Committee Backs Approval of MSD’s Insomnia Treatment
August 4, 2014
- JPMA to Examine Clinical Trial Costs
August 1, 2014
- Improvement Order Issued to Novartis over Delayed ADR Reporting
August 1, 2014
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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…