On December 10, Biogen/Eisai’s controversial Alzheimer’s treatment aducanumab was filed for regulatory approval in Japan. It’s unclear whether Japanese regulators…
REGULATORY
MHLW Informs of New Guideline on Exemption from Bioequivalence Studies for Oral Drugs
The Ministry of Health, Labor and Welfare (MHLW) has issued a notification informing of ICH’s guideline on Biopharmaceutics Classification System (BSC)-based Biowaivers, which eliminates the need for bioequivalence studies of oral drugs under certain conditions. Biowaivers eliminate the need for…
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REGULATORY
- Administrative Penalty on Nichi-Iko Possible by March-End over Recalls
January 15, 2021
- Special Mitigation Margin for COVID-19 Up for Debate towards FY2022 Drug Price Revision: MHLW Bureau Chief
January 15, 2021
- MHLW Initiates Discussions on Amendment of Clinical Research Law
January 15, 2021
- Thaled Up for PAFSC Review for POEMS Syndrome on Jan. 27
January 15, 2021
- Chuikyo to Discuss Health Coverage for Fertility Treatments from This Summer
January 14, 2021
With a tumultuous year heading towards a close, let us share the 10 most-read stories on PHARMA JAPAN in 2020. With 2020 being a biennial drug price revision year, our global readers apparently had their eyes riveted on which products…
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…
As we navigate the lingering effects of the global pandemic, one thing is unmistakably clear - change is here. We’ve changed, and so have our companies. The entire workplace has transformed, but it’s not always a change for the better.…