Japan Updates the GMP Compliance Inspection FAQs

On August 18, 2023, Japan's Pharmaceuticals and Medical Devices Agency (PMDA) updated the frequently asked questions (FAQs) for compliance inspection of Good Manufacturing Practice (GMP). As revealed by the GMP Ministerial Ordinance, when manufacturing quasi-drugs designated by the Minister of Health, Labour and Welfare (MHLW), the product shall comply with GMP through manufacturing control and quality management. Besides, an application for GMP compliance inspection is necessary.

This FAQs update primarily addresses issues related to online submissions.

Q1: If the application is submitted online, will all inquiries and responses from PMDA be made through the “gateway system*”?

*Gateway system is a system used for online submission of applications, notifications, and other requirements specified by the Pharmaceutical and Medical Devices Act.

If the inquiry is directed to someone other than the applicant (e.g., the domestic representative of the Marketing Authorization Holder), the inquiry will be made through traditional methods such as fax, mail, and email.

Q2: When submitting multiple applications, is it necessary to obtain a gateway reception number for each application? Alternatively, can multiple applications be made under a single gateway reception number?

In principle, please submit one application under per gateway reception number. However, in the case of investigations related to the same manufacturing site, it is allowed to submit multiple investigation applications under a single Gateway reception number. For example, this applies when submitting compliance inspection applications for multiple formulations with different contents but from the same manufacturing site.

Q3: The Submission Method for Documents via Email for GMP Compliance Inspection, etc., requires the inclusion of the investigator's name in the email subject. So, what should be done when submitting some documents for a compliance inspection application with no assigned investigator, and there is a delay in submission?

In principle, please submit the compliance inspection application when all the necessary documents are ready. In cases where there is a delay in submitting some of the documents, and no investigator in the Pharmaceutical Quality Management Department has been assigned, please indicate "Investigator Not Assigned" instead of the investigator's name in the email subject.

Background information

In Japan, cosmetics (broadly defined as beauty products) are legally classified into two categories: cosmetics and quasi-drugs. Cosmetics are not subject to GMP requirements. However, when manufacturing designated quasi-drugs, they are necessary to undergo GMP compliance inspection.

The purpose of GMP inspection is to ascertain whether their manufacturing facilities, manufacturing and quality controls comply with standards, and whether the manufacturing sites have a system for manufacturing products with adequate quality.

GMP inspections are categorized into two types: new inspections and regular inspections.

1. New inspections: compliance inspection for applications of manufacturing licenses and marking licenses as well as applications for change approval

2. Regular inspections: after the approval of the manufacturing and sales licenses, a conformity survey will be carried out every 5 years.