Japanese Regulation on GMP/GQP and Its Challenges

Good manufacturing practice (GMP; see first comment in article note) and good quality practice (GQP; see second comment in article note) defined in Pharmaceutical Affairs Law (PAL) are crucial regulations for assuming the quality, efficacy, and safety for pharmaceutical products in Japan. The revision of Pharmaceutical Affairs Law in 2002 which entered into force in April 2005 has brought significantly impact for stakeholders, and it is still challenging for both of regulators and industries. In the new PAL, concept of the marketing approval holder, who has all of the responsibility for the products provided in Japan and has to meet GQP criteria, has been introduced and raised fundamental change for pharmaceutical regulation. However, there are some cases that marketing approval holder did not have appropriate information of manufacturing site which was required by the PAL and GQP that seems the marketing approval holder did not understand properly the revised PAL and GQP. In this manuscript, we show the points of PAL revisions focusing the GMP/GQP-related issues and also explain the challenges to encourage the understanding of Japanese regulations, particularly for foreign company who are exporting the pharmaceutical products into Japan.