REGULATORY

New MHLW Drug Review Chief Vows to Make Japan Attractive Place for Clinical Trials, Watching Debate on Japanese PI

By Ken Yoshino September 12, 2023
In a bid to stem the trend of drug lags and losses, the Ministry of Health, Labor and Welfare (MHLW) will roll out policies to boost the attractiveness of Japan’s clinical trial environment, while streamlining operational procedures and discussing the…

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REGULATORY

Japan’s health ministry approved a slew of new medicines on September 25 including multiple “first of its kind” products, among them being GlaxoSmithKline’s respiratory syncytial virus (RSV) vaccine Arexvy as well as Eisai’s Alzheimer’s therapy Leqembi (lecanemab).Arexvy became the first…

By Philip Carrigan

“Time is the scarcest resource, and unless it is managed, nothing else can be managed.” - Peter DruckerSearching for the right candidate takes time… but how much time?The last thing you want is to waste time searching for the wrong…

By Yoshinori Sagehashi

A doctor member of the Central Social Insurance Medical Council (Chuikyo) on September 20 traded barbs with pharma leaders over…

By Ken Yoshino

The Ministry of Health, Labor and Welfare (MHLW) on September 19 proposed restructuring the Japanese generic industry by restricting the…

By Yoshinori Sagehashi

The Ministry of Health, Labor and Welfare (MHLW) plans to no longer require the implementation of additional PI clinical studies…

By Izuru Ando

In early September, Japan released its second package strategy for software as a medical device (SaMD), dubbed “DASH for SaMD 2”. With new measures added to its first edition compiled in 2020, the new strategy embraces “predictability” and “international expansion”…

By Yoshinori Sagehashi

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…