Japan Drug Registration: New GMP Requirements

Registering drugs in Japan can be a very tedious process, but the benefits can also be quite large. Japan has a large aging population that heavily relies on new and innovative drugs. Besides a dossier product submission, drug companies need to obtain GMP approval per MHLW’s Ordinance 179 (2004) for drug approval. A GMP audit is usually needed for a new drug approval, a partial change submission and after a drug is appoved every 5 years. All documents submitted for your GMP must be in Japanese and include many documents covering – 1. Quality sytems, 2. Facility/Equipment systems, 3. Storage systems for finished Products, intermediates and raw materials, 4, Analytical testing systems, etc.

Recently the MHLW decided to strengthen the GMP system in Japan to increase efficiency and quality. In the past, provincial government officials audited generic and some other drug factories, while the PMDA did audits at factories with innovative or more risky drug factories.  However, the PMDA saw that some provinces had a high number of inspections and others a low number of inspections. Also, the MHLW has determined that some of the GMP auditors were more qualified than others, thus showing a lack of consistency in the review system.

In an effort to make GMP audit inspections more transparent and consistent and increase the overall knowledge of the auditors,  the PMDA has decided that all Japanese inspections reports will be shared throughout Japan. This sharing will help all inspectors learn more about a variety of complex GMP issues they may not have seen in their province, and hopefully, allow inspectors to spot issues more quickly.

In addition, the MHLW is setting up more training programs on GMP compliance. The GMP training program will include more seminars, delve further into legal issues, and provide easier access to international GMP regulators and regulations. The above efforts should hopefully standardize the training of inspectors and put them in a better position to find violations earlier on.

Finally, the MHLW indicated late last year that prefectural government officials accompanied by PMDA officials will do more surprise GMP inspections going forward especially at factories with some recalls, many adverse events, etc. to improve drug quality in Japan.

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.

Source used in the article: https://www.pmda.go.jp/english/about-pmda/0004.html