Role and Expected Future Development of the Japanese Pharmacopoeia

Abstract

In the Basic Principles for the Preparation of the Japanese Pharmacopoeia (JP), 18th edition, the JP is referred to as an official document that defines the specifications, criteria, and standard test methods necessary to properly ensure the quality of medicines in Japan and as a public property that should be widely used by all parties concerned, such as pharmaceutical administrations, companies, and those involved in research, education, and medical practice. In addition, it states that the JP should play an appropriate role of providing information and proper understanding of drug quality to the public and should promote and maintain advances, consistency, and harmonization of technical requirements in the international community. These show that the JP not only contributes as a written standard but also as a provider of information on test methods and international understanding for drug quality control. JP articles refer to a wide range of drugs at various phases of the product life cycle, as it should cover all drugs in terms of importance from the healthcare viewpoint. When the JP is viewed from a panoramic perspective, these are the reasons why its contents are extremely profound and complex. This report discusses the JP's role and expected future as a scientific document from the author's viewpoint as a JP Expert Committee member for more than 30 years.