Japan's PMDA issues guidance for reviewers
This article was originally published in Scrip
Japan's drugs and medical devices regulator, the PMDA, has now made available through its website an English translation of a "points to consider" document which outlines the type of information the agency is looking for from applicants and how this should be assessed by its review teams.
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While it was not as affected as some other countries, Japan still had the pandemic to deal with and regulators responded while managing to keep up regular product review work, including several world-first approvals. Coronavirus vaccine roll-outs and the first general annual reimbursement price cut are on the cards for this year.
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