GPMSP (good post-marketing surveillance practice)

医薬品の市販後調査の基準

GPSP (good post-marketing study practice)

医薬品の製造販売後の調査及び試験の実施の基準

GVP (good vigilance practice)

医薬品、医薬部外品、化粧品及び医療機器の製造販売後安全管理の基準

Japan’s contract drug rep ratio rose to 8.7% in FY2024 as the total number of regular reps continued to fall, the Japan Contract Sales Organization Association (JCSOA) reported in June. Amid industry downsizing, the roles and expectations placed on contract…

A recent conversation with a US biopharma senior director highlighted a critical talent gap: a strong demand for individuals with strategic management, critical thinking, and advanced business acumen-skills beyond traditional operational excellence. After the conversation, I rushed home and picked…

The Japanese government approved a bill to amend the Pharmaceuticals and Medical Devices (PMD) Act at its Cabinet meeting on…

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

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…

The Ministry of Health, Labor and Welfare (MHLW) posted the final report compiled by its pharmaceutical regulation panel on its website on April 24, providing cases of drugs that could be exempted from all-case post marketing surveillance (PMS).The MHLW plans…

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

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