REGULATORY

MHLW Revises Notifications on Electronic Data Submission as End of Grace Period Approaches

January 28, 2019
The Ministry of Health, Labor and Welfare (MHLW) on January 24 partially revised two notifications regarding electronic study data submissions for new drug applications, eyeing the termination of the grace period at the end of March 2020. The submission of electronic…

To read the full story

REGULATORY

By Reiji Anasako

Kyowa Hakko Kirin’s first and only Rituxan (rituximab) biosimilar in Japan is showing a faster-than-expected uptake in the market, with the company racking up 4.3 billion yen from the cancer drug in 2018, far beyond its initial 3.2 billion yen…

Members of a key reimbursement policy panel appear to be becoming more and more open to the industry’s call for…

By Takashi Ebisawa

A series of drug makers restructured or sold off production facilities in FY2018. Others dissolved or withdrew from the pharmaceutical business altogether. The entry of generics and transfer of products triggered these moves, but the underlying factor was the impact…

By Philip Carrigan

With a cursory glance, recruitment is easily defined. We’re here to help place candidates into the vacancies our clients need to fill. Armed with a pen and paper, you could even map out the process.• We study the market• We…