“The Tesla and SpaceX CEO sent an email to employees at both companies on Tuesday saying everyone must spend 40 hours per week in the office. ‘If you don’t show up, we will assume you have resigned. The more senior…
ORGANIZATION
Osaka-Based NPO to Take on Outsourcing of GMP Compliance Audit on Drug Substance Makers
An Osaka-based non-profit organization is set to launch an outsourcing service in mid-March to audit drug substance makers’ compliance with Japanese Good Manufacturing Practice (GMP) requirements on behalf of pharmaceutical companies. By tapping the expertise of GMP-savvy retirees of regulatory…
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ORGANIZATION
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Pharma companies have seen Japan’s new “zero” premium coefficient rule extensively applied to medicines with low cost disclosure ratios since its introduction under the drug pricing reform this April. Of new drugs listed in the past two months, all six…
The average ratio of females in managerial posts at Japanese drug makers has finally reached a double-digit number, at 10.0%, a Jiho survey found. However, this is still well below a near-25% ratio logged by foreign players operating in the…
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…
A total of 15 new drugs (APIs) joined the NHI price list in 2021 with peak sales forecasts topping at 10 billion yen, many of them in the area of orphan diseases and with few mega launches, according to a…