GMP and Quality Regulation in Japan

The GMP and Quality Regulation in Japan is very important for all international operating companies. However, although Japan is part of the International Conference on Harmonisation there are still some major differences in the regulation with regard to manufacturers of APIs and medicinal products.

Most people are not aware that the Japanese Pharmaceuticals and Medical Device Agency's (PMDA) website is well designed and provides a good overview about the requirements in English language. For that reason you will find following some links to the most relevant sections regarding GMP and Quality Regulations.

The Japanese Regulations and Procedures are structured in the following order:

  • Accreditation of Foreign Manufacturers 
  • Master File System 
  • GMP 
  • QMS 
  • Notifications 
  • Ministerial Ordinances 
  • Other Regulatory Actions 
  • Application for Approval-Frequently Asked Questions (FAQ) 
  • ICH Information (in Japanese) 

For further information please see the structure.

One of the most relevant Guidelines is the Ministerial Ordinance on GMP.

For API Manufacturers the Drug Master File procedure is of great importance. The PMDA offers some very good information about the regulatory requirements including a list of Question & Answers in English language. It is available here.

In addition to the European Pharmacopoeia (EP) and the United States Pharmacopoeia (USP) the Japanese Pharmacopoeia (JP) is one of the three most important Pharmacopoeias. There is even the possibility to access the English Version of the 15th Edition of JP free of charge!

Very few speakers from Japanese Authorities have been invited to present the Japanese requirements in Europe yet. At the European GMP and Regulatory Affairs Conference on APIs in Barcelona, Spain, from 27-29 October 2010, Yoshikazu Hayashi, PMDA Liaison Official at the EMA will speak about Regulatory requirements with regard to APIs in Japan.

Oliver Schmidt
On behalf of the European Compliance Academy (ECA)

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