The Ministry of Health, Labor and Welfare (MHLW) appears to be ready to begin post-launch drug price adjustments based on cost-effectiveness assessments (CEAs) for the first time since the system was introduced in April 2019. As price tweaks will be…
REGULATORY
Ex-PMDA Inspector Urges Improvements in Japanese Inspection Systems after GMP Scandals
Japanese generic majors Kobayashi Kako and Nichi-Iko Pharmaceutical incurred administrative sanctions in February and March, respectively, due to GMP violations over the years. Why didn’t inspectors identify these problems sooner? Shingo Sakurai, a former inspector with the Pharmaceuticals and Medical…
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REGULATORY
- Vaccine Industry Group Calls for Govt’s Control Functions for Infectious Diseases
April 21, 2021
- Japan Officially Announces CEA-Based Prices for Kymriah/Trelegy, Effective July 1
April 21, 2021
- FPMAJ Chief Calls for Uninterrupted Govt Support for Japan-Made Vaccines Even in Ordinary Times
April 20, 2021
- Over 50% of Itraconazole ADR Reporting Comes from Pharmacists in October-December: PMDA
April 20, 2021
- Japan to Secure Enough Vaccines for All People by September: Suga
April 20, 2021
Biogen’s controversial Alzheimer’s drug aducanumab was filed for Japanese regulatory approval in December. If approved, it will be the first…
Japan’s key reimbursement policy panel on December 20 approved an outline of its FY2020 drug pricing reform next April, with…
The Ministry of Health, Labor and Welfare (MHLW) on November 27 added to the NHI price list Japan’s first biosimilars of Avastin (bevacizumab), Nesp (darbepoetin alfa), and Forteo (teriparatide). The NHI prices of first biosimilars are set at 70% of…
Japan will go ahead with the introduction of a cost-effectiveness assessment (CEA) scheme for drugs and medical devices in April…
After decades in recruitment, I say from experience that there’s a particular way to attract candidates to a given role. Do it right, and you’ll have talent chasing you. Get it wrong, and you’ll be left listening to the crickets…