2018 Volume 8 Issue 2 Pages 55-68
The Japanese Pharmacopoeia (JP) is promoted internationalization in line with globalization of supply chain for pharmaceuticals. For example, harmonization of test methods and monographs is conducted by Pharmacopoeial Discussion Group (PDG) which consists of JP, the United States Pharmacopeia (USP), and the European Pharmacopoeia (Ph. Eur.). In addition, utilization of JP as a reference pharmacopoeia in Asian region is aimed by the Ministry of Health, Labour and Welfare and Pharmaceuticals and Medical Devices Agency of Japan. Therefore, to clarify characterization of JP comparing with USP and Ph. Eur. utilized worldwide is useful for harmonization activity in PDG and getting all users to use JP appropriately. Then, we compared the three pharmacopoeias about constitution, general notices which are fundamental to understand pharmacopoeia and status of provision on control of impurities which is one of the highest interest in the area of pharmaceutical quality. As a result, although the constitution among three pharmacopoeias was not completely same, their basic concept that the test methods and monographs are described in assuming following the general notices was common. In addition, all three pharmacopoeias stated comprehensive rule in general notices. The comparison also clarified that JP uses a term of “Being specified separately” in the general notices 11 to describe a relationship with approval documents, but USP and Ph. Eur. didn’t have such a provision. Furthermore, Ph. Eur. and USP had more chapters for control of impurities than JP. In consideration of these similarities and differences among three pharmacopoeias and characteristics of JP, we expect that JP will be not only enriched its contents but also more convenient for users.
