REGULATORY

GMP Inspections to Be Conducted Unannounced as Basic Rule: MHLW

July 30, 2021
The Ministry of Health, Labor and Welfare (MHLW) revised its GMP inspection guidelines for the first time in nine years. Under the new rules, on-site inspections will be carried out with no prior notifications as a basic rule. The update…

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REGULATORY

By Ludwig Kanzler

As reported previously, Reed Maurer passed away on August 30 due to complications from pneumonia. He was approaching his 84th birthday.Reed has been a driver of the international pharma community in Japan like nobody else. Arriving over fifty years ago…

By Takashi Ohama

Over two years after the rollout of the cost-effectiveness assessment (CEA) scheme in April 2019, discussions on its system reform are set to go into full swing at a key reimbursement policy council known as Chuikyo. Both payer and healthcare…

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Japan’s key reimbursement policy panel on December 20 approved an outline of its FY2020 drug pricing reform next April, with…

Japan will go ahead with the introduction of a cost-effectiveness assessment (CEA) scheme for drugs and medical devices in April…