LEXICON
No.105 March 12, 2012

Drug marketing license (authorization) holder; drug marketer
医薬品製造販売業者
First-class drug marketing license (authorization) holder; first-class drug marketer
第1種医薬品製造販売業者
Second-class drug marketing license (authorization) holder; second-class drug marketer
第2種医薬品製造販売業者

The Pharmaceutical Affairs Law (PAL;薬事法) which went into effect in April 2005 separated drug manufacturing (製造) from marketing (製造販売), allowing companies without their own manufacturing facilities (製造設備) to market drugs manufactured by other companies (manufacturing license holders;製造業者). Drug marketing license...

To read the full story

LEXICON

By Philip Carrigan

As CEO of Morunda, I had the privilege of interviewing Bill Schuster, Country Manager of Viatris in South Korea. Our conversation delved into the multifaceted nature of leadership in the healthcare industry, exploring challenges, successes, and the power of authenticity.A…

By Shinya Sato

A total of 43 innovative new medicines are anticipated to be approved or listed in Japan this year, according to a survey by Jiho. At the center of attention are some highly innovative, but probably ultra-expensive, gene therapies, as well…

By Takashi Ebisawa

A Japanese health ministry panel on December 26 wrapped up its discussions on the next amendment of the Pharmaceuticals and…

Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…

By Ken Yoshino

Japan’s key reimbursement policy panel on December 25 approved an outline of the FY2025 drug price revision, finalizing plans to…

For the first time in many years, Japan appeared to have pivoted to a pro-innovation path with the FY2024 drug pricing reform. All eyes were apparently on this course change as seen in this year’s most-read story list, though the…

A Japanese health ministry panel discussing the generic industry structure on May 22 put together a report in which it…

A Japanese health ministry study group focused on pharmaceutical regulations on March 21 agreed on a policy to encourage the…

Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…

By Yoshinori Sagehashi

The Japanese health ministry’s expert panel tasked to discuss comprehensive policies for the rapid and stable supply of pharmaceuticals generally…