Similarities and Differences of International Practices and Procedures for the Regulation for Active Substance Master Files/Drug Master Files of Human Use: Moving Toward Regulatory Convergence

Matsuhama, Maki; Takishita, Tomoko; Kuribayashi, Ryosuke; Takagi, Keiichi; Wakao, Rika; Mikami, Katsuhiro

doi:10.18433/j37g80

Cited by 3 publications

(1 citation statement)

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“…15) The JP is officially recognized in various coun-tries, including Brazil, Singapore, South Africa, South Korea, Taiwan, and Thailand. 16,17) Furthermore, the JP is actively incorporating concepts of quality assurance based on the latest knowledge in the field, promoting the dissemination of the JP as a reference pharmacopoeia in other countries and regions, especially in Asian countries, and aiming to contribute to improving the quality of medicines distributed globally. 18,19) With the globalization of medicine supply chains, manufacturers are required to manufacture products in compliance with the pharmacopoeial standards used in all exporting countries/regions; thus, the need to confirm and ensure compliance with the three widely used pharmacopoeias, i.e., the JP, USP, and Ph.…”

Section: Introductionmentioning

confidence: 99%

Comparative Study of General Notices in Pharmacopoeias in Japan, the United States, and Europe

et al. 2023

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Globalization of pharmaceutical supply chains has expanded and manufacturers are required to manufacture products in compliance with the pharmacopoeial standards used in all exporting countries/regions to ensure product quality. International harmonization has been facilitated by the Pharmacopoeial Discussion Group consisting of the Japanese Pharmacopoeia, the United States Pharmacopeia, and the European Pharmacopoeia. However, since the pharmacopoeias have been developed individually under the regulatory framework of each country/region, differences exist between these pharmacopoeias. When using pharmacopoeias, an understanding of common pharmacopoeial rules is essential. Clarifying the similarities and differences in the General Notices of the pharmacopoeias widely referenced worldwide is considered valuable for those already using one or two of them to access the remaining pharmacopoeias. In this study, we compared the existence of items and the contents described in the General Notices of the three pharmacopoeias to clarify the differences. Investigation of the existence of items revealed that more than 70% of the 105 items in General Notices in the three pharmacopoeias were in the entire pharmacopoeias (for Japan, including Japanese laws and notifications). Furthermore, investigating contents revealed that approximately 20% of the 105 items have some differences such as numerical values and test conditions. However, it was shown that most of the items did not have major differences. It is expected that the three pharmacopoeias will be utilized simultaneously by understanding the similarities and differences shown in this study.

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Section: Introductionmentioning

confidence: 99%