Upcoming Change to Japan’s GMP Compliance Audit Authorities

On January 19, 2011, newspapers in Japan published an announcement from the Ministry of Health, Labour and Welfare (MHLW) on an upcoming change to the good manufacturing practice (GMP) compliance audit. It had been previously announced that manufacturers creating products that are sold in Japan who have completed the first of their annual GMP audits with the Pharmaceuticals and Medical Devices Agency (PMDA) will subsequently be inspected annually by prefectural and city governments. This would be change from the current system where the PMDA conducts all of the initial and subsequent GMP audits.

The latest announcement explains that the transition to this new model will occur soon. Near the end of March, the Order for Enforcement of the Pharmaceutical Affairs Act will be revised. Following three months of preparation time, relevant notices will be released and implemented as of July 1, 2011.
The overall goal of this change is to shorten GMP processing time.

In Japan, GMP refers specifically to pharmaceuticals. Annual GMP audits have been required in Japan since 2005. PMDA Notification No. 1130005 was released on November 30, 2005, and it includes guidelines for GMP audits.