No.81 September 12, 2011

Marketing authorization holder
Sales, distribution/distributor
Marketing/marketer (marketing authorization holder)

The amended Pharmaceutical Affairs Law (PAL;薬事法), which went into effect in April 2005, has introduced a new marketing business licensing system (製造販売業の許可体系) and has changed the conventional manufacturing approval system (製造承認制度) to the new marketing approval system (製造販売承認制度). Under the...

To read the full story


By Eric Persoff

There has been a growing trend of life science manufacturers collaborating with local governments (e.g., at the municipal and prefectural level) in Japan during the past 3-5 years. This trend is observed not only with domestic manufacturers but among foreign…

By Izuru Ando

Shionogi’s COVID-19 pill ensitrelvir failed to clear the second round of review by a key advisory panel on July 20. The session drew a great deal of attention since the drug is the first candidate for the application of Japan’s…

By Reiji Anasako

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…