A Comparison of Update Cycle and Characteristics of Pharmacopeia of Each Country (1)

Pharmacopeia is the code of a country to record the pharmaceutical product standards and specifications, generally compiled by the national pharmacopoeia commission, and approved and promulgated for implementation by the national pharmaceutical product administration, while the international pharmacopeia is compiled and corrected by a recognized international organization or relevant countries through consultation. The update cycle of pharmacopeia of each country differs, and characteristics thereof also differ. Pharmacopeia of each country is summarized and compared here in this article.

Chinese Pharmacopoeia (CP):

It is familiar to us.

Issuance history and latest edition

The Pharmacopoeia of the People's Republic of China (hereinafter referred to as the CP), compiled by the Chinese Pharmacopoeia Commission, is currently published and updated every five years, with the latest edition of the CP 2015 Edition and the 10^th edition since new China was founded.

Characteristics of the CP

The CP 2015 Edition comprises four volumes and contains a total of 5,608 varieties; Volume I contains a total of 2,598 TCM varieties, including 440 new admissions, 517 new revisions, and 7 rejections; Volume II contains a total of 2,603 chemical drug varieties, including 492 new admissions, 415 new revisions, and 28 rejections; Volume III contains a total of 137 biological product varieties, including 13 new admissions, 105 new revisions, 1 new general requirement for biological products, 3 new general chapters of biological products, and 6 rejections; Volume IV contains a total of 317 general requirements (appendices), including 38 general requirements for preparations integrated and revised from Volume I, Volume II and Volume III, 278 testing method appendices, 18 new testing methods, and 15 guiding principles. 270 pharmaceutical excipient varieties are contained, including 137 new admissions, 97 new revisions, and 2 rejections (Table 1).

Table 1 Summary Table of New Admissions and New Revisions of CP 2015 Edition

Japanese Pharmacopoeia

Issuance history and latest edition

The Japanese Pharmacopoeia (JP) is compiled by the Society of Japanese pharmacopoeia, and promulgated for implementation by the Ministry of Health, Labour and Welfare. The JP is updated once every 5 years during which, the edition will be revised, and 2 supplements will be published. The latest edition is JP17 (including Supplement I). Each previous edition is as shown in the following table: https://www.pmda.go.jp/files/000210780.pdf

Table 2 Update Situation of JP

Characteristics of the JP

The JP is published in two volumes, with Volume I including APIs and basic preparations thereof, and Volume II mainly including crude drugs, household medicine preparations and preparation APIs.

Indian Pharmacopoeia

Issuance history and latest edition

Indian Pharmacopoeia (IP) is the quality standard for drugs produced in India, which must be controlled quality according to the content specified therein. The first edition of IP was published in 1955 after the independence. The new edition of IP is edited and published by the Indian Pharmacopoeia Commission. Currently, the update cycle of IP is 4 years (based on the situation of recent eight years), and there will be supplements between editions. The latest edition is IP2018, which is the eighth edition after India independence. Situation of each edition of the IP is as shown in the following table, and the work plan is published by the Indian Pharmacopoeia Commission online. http://ipc.nic.in/showfile.asp?lid=889&EncHid

Table 3 Update Situation of IP

Characteristics of the IP

The IP is divided into three volumes. Volume 1 contains the Notices, Preface, the Structure of the Indian Pharmacopoeia Commission, and General Chapters; Volume 2 contains APIs, preparations, and pharmaceutical excipients (A to M); Volume 3 contains APIs, preparations, and pharmaceutical excipients (N to Z), and also Vaccines and Immunosera for Human use, Herbs and Herbal products, Blood and blood-related products, Biotechnology products and Veterinary products.

International Pharmacopoeia (Ph.Int)

Issuance history and latest edition

Based on the work and resolution of WHO (World Health Organization) Expert Committee on Specifications for Pharmaceutical Preparations, the International Pharmacopoeia (Ph.Int) was published the first edition in two volumes separately in 1951 and 1955, and was thereafter updated the edition separately in 1967, 1975, 2006, 2015, 2016, and 2017, showing no law in terms of the update cycle, however, according to the latest update law, almost one edition is updated every year. Currently, it reaches the seventh edition in 2017.

Characteristics of the Ph.Int

Ph.Int is compiled and published by WHO for the free access of WHO member states. Many countries, especially the African member states, regard Ph.Int as a standard recognized by the countries or regions, namely, with legal force. The Ph.Int contains General Notices, Monographs, Methods of Analysis, Infrared reference spectra, Reagents, test solutions and volumetric solutions, and Supplementary information. General Notices comment nearly 30 items in the Monographs; Monographs include APIs, excipients, preparations and radiopharmaceuticals. The fifth edition of the Ph.Int collects 443 APIs and excipients, 145 preparations, and 27 radiopharmaceuticals in total; the Infrared reference spectra (fifth edition) contain infrared spectra of 174 varieties. The Methods of Analysis includes five methods like Physicochemical Methods.

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