Japan’s MHLW Plans Unannounced GMP Drug Inspections

Meeting Japanese drug GMP requirements is a key factor for drug registration in Japan. In the past, pharmaceutical inspections were done by prefectural governments at generic and other drug factories, and the PMDA did inspections at factories with high-risk drug products, like biologics. However, the MHLW has seen that the number of inspections was high in some prefectural governments and low in others. In addition, the MHLW has claimed that the number of qualified inspectors at some prefectures is low, and these inspectors often lack GMP knowledge.

Thus, in mid-November, a panel of the MHLW recommended that going forward, both the PMDA and appropriate prefectural government inspectors will do surprise GMP inspections together. Beginning at the end of Japan’s fiscal year, inspections without notice will be initiated at drug factories in the following scenarios – the drug is manufactured utilizing a special technology, the drug manufacturing process is considered complicated, there have been adverse events, recalls of the drug, or previous negative inspection reports, etc. By doing joint inspections, the MHLW hopes that the PMDA will impart GMP inspection knowledge to prefectural inspectors. At the same session, it was suggested that Japan change its GMP requirements from a product-based system to a Western system that focuses more on reviewing factory sites.