Japan's biosimilar guidelines edge forward
This article was originally published in Scrip
Japan's regulator, the PMDA, expects to finalise a new guideline for the regulation of follow-on biologics this year, following the first draft put out for public comment last September. This prompted a flood of more than 300 suggestions, some of which the agency and ministry of health, labour and welfare are now working to include into the revised version, Dr Teruhide Yamaguchi of the country's National Institute of Health Science told a meeting in Tokyo.
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Join us for a brief audio tour around the past week's major global biopharma industry developments, in this podcast version of Scrip's Five Must-Know Things.
Highlighting progress it has made over the past few years, Japan’s regulatory agency says it wants to raise even further the number of “Japan-first” approvals, as part of its stated mission to get safe and effective new drugs to patients more quickly.
Join us for a brief audio tour around the past week's key developments in the global biopharma industry, in this podcast version of Scrip's Five Must-Know Things.