On July 7, Japan’s PMDA published its GMP annual report for 2024. Japan’s PMDA has reported that many foreign drug companies are not meeting Japan’s GMP standards. In 2024, there were 126 on-site GMP inspections and 2,049 desktop GMP inspections. These figures represent double the number of on-site inspections and four times the number of desktop inspections conducted in 2023.
A Japanese GMP inspection is a prerequisite for approval for a new drug, drugs with recombinant technology, or any drugs that have living or human organisms as raw materials or radiopharmaceuticals. GMP inspections are done every 5 years. Shortly after an inspection, deficiencies are put into 3 levels: critical, major, and other. As a result of these findings, the PMDA wants to improve its requirements with foreign drug companies and has published an English version of the GMP Ministerial Ordinance on its website in July 2024.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.