A relevant official from the Veterinary Bureau of the Ministry of Agriculture answered reporters' questions regarding the official implementation of the 2010 edition of the "Chinese Veterinary Pharmacopoeia."

【Summary Description】 On July 1, the 2010 edition of the China Veterinary Pharmacopoeia was officially implemented nationwide. This edition is the fourth since the initiation of veterinary pharmacopoeia compilation in 1985, and it represents the most comprehensive collection of national veterinary drug standards to date. Compared with previous editions of the veterinary pharmacopoeia, what are the major changes introduced in the new edition? And how will these changes affect the quality of veterinary drugs as well as the management, production, distribution, and use of veterinary medicines? Our reporter interviewed a relevant official from the Veterinary Bureau of the Ministry of Agriculture.

On July 1, the 2010 edition of the China Veterinary Pharmacopoeia was officially put into effect nationwide. This edition is the fourth since the compilation of the Veterinary Pharmacopoeia was initiated in 1985, and it represents the most comprehensive collection of national veterinary drug standards ever published. Compared with previous editions of the Veterinary Pharmacopoeia, what are the key changes in the new edition? And how will these changes affect the quality of veterinary drugs as well as the management, production, distribution, and use of veterinary medicines? Our reporter interviewed a relevant official from the Veterinary Bureau of the Ministry of Agriculture.

　　 Q: What is the practical significance of the promulgation and implementation of the new edition of the Veterinary Pharmacopoeia for the development of the veterinary drug industry?

　　 Answer: The Veterinary Pharmacopoeia is the cornerstone of national veterinary drug standards; it serves as the nation’s technical code for veterinary drugs and constitutes the legally binding reference that all entities involved in the production, distribution, use, and management of veterinary drugs must strictly adhere to. After nearly 30 years of reform and development, China’s veterinary drug industry has gradually evolved into an industrial system characterized by relatively comprehensive categories, a relatively diverse range of products, advanced technologies, a well-integrated industrial chain, and a degree of international competitiveness. As of now, there are a total of 1,715 veterinary drug manufacturing enterprises nationwide, producing nearly 2,000 varieties across 29 dosage forms. Some of these products are also exported to regions such as North America, Europe, Southeast Asia, and Africa. However, due to the relatively late start of standard-setting efforts in China’s veterinary drug sector and the resulting lag in the development of its standardization system, the overall level of China’s veterinary drug industry has been hindered. Therefore, it is highly necessary to continuously update and enhance the scientific rigor, advanced nature, standardization, and practicality of veterinary drug standards. Raising the standards for veterinary drugs is essential for strengthening regulatory capacity and technological innovation within the industry, and it is crucial for achieving healthy and sustainable development of the veterinary drug sector.

　　The new edition of the Veterinary Pharmacopoeia adheres to the "Regulations on the Administration of Veterinary Drugs" and relevant laws and regulations, fully reflecting the characteristics of our times and better embodying the principles of distinctiveness and advancement, science and practicality, standardization and improvement. It is well-suited to the current realities of veterinary drug production, distribution, and management in China, as well as to the actual levels of veterinary drug testing and clinical application. At the same time, this edition of the Veterinary Pharmacopoeia is grounded in standardizing and perfecting veterinary drug quality standards, enhancing their scientific and technological content and advanced nature, and further aligning with international standards. Its publication and implementation reflect China’s latest achievements in both veterinary drug quality and usage standards, and hold significant importance and a crucial role in perfecting China’s veterinary drug standard system, promoting the rational use of veterinary drugs, safeguarding the safety of animal products, and fostering the healthy development of the veterinary drug industry.

　　 Q: The compilation of the Veterinary Pharmacopoeia is a highly specialized undertaking. Could you please explain how the new edition of the Veterinary Pharmacopoeia was developed? Which departments and institutions were involved in the drafting process?

　　 Answer: The Ministry of Agriculture has always attached great importance to the compilation of the Veterinary Pharmacopoeia. Since the initiation of the Veterinary Pharmacopoeia compilation work in 1985, the Ministry has established four committees and successfully completed the revision and promulgation of the 1990, 2000, 2005, and 2010 editions of the Veterinary Pharmacopoeia. Looking back at the process of revising and promulgating the Veterinary Pharmacopoeia, we can see that it has evolved from nothing to something, with its content becoming increasingly scientific and comprehensive, its quality continuously improving, and its standards gradually aligning with advanced domestic and international levels—fully demonstrating its scientific rigor, advanced nature, standardization, and practicality. In particular, the compilation of the 2010 edition of the Veterinary Pharmacopoeia took nearly five years—from its full-scale launch in April 2006 to the completion of the revision. The China National Veterinary Drug Administration, 29 provincial veterinary drug supervision institutes, 12 colleges and universities, 23 research institutions, and 11 enterprises, along with 220 experts from fields including chemical drugs, antibiotics, drug evaluation, biological products, and traditional Chinese medicine—covering research, production, inspection, and supervision—participated in the compilation of the new edition of the Veterinary Pharmacopoeia. All participating units and experts fully leveraged their professional strengths, actively undertook scientific research tasks, and diligently carried out the drafting, review, and revision of the standards included in the new edition of the Veterinary Pharmacopoeia. According to statistics, from the establishment of the Fourth Veterinary Pharmacopoeia Committee in June 2006 until the completion of the compilation, a total of 47 specialized meetings—including division-of-labor meetings, appraisal meetings, and seminar meetings—were held, attracting a total of 1,419 participant-times. Additionally, 38 rounds of manuscript reviews by correspondence were organized as needed. It is fair to say that all participating units and experts have made arduous efforts and significant contributions to the compilation of the new edition of the Veterinary Pharmacopoeia.

　　 Q: Compared to the 2005 edition of the Veterinary Pharmacopoeia, what changes have been made in terms of scope and content in the new edition?

　　 Answer: The scope and content of the Veterinary Pharmacopoeia reflect a country’s overall level of veterinary drug standards. Compared with the previous edition, the 2010 edition includes more extensive and broader content. Building on the experience gained from previous editions of the Veterinary Pharmacopoeia, the 2010 edition further expanded its coverage, essentially establishing a comprehensive system of veterinary drug standards covering categories such as chemical drugs, antibiotics, biochemical drugs, pharmaceutical excipients, traditional Chinese medicinal materials and processed slices, vegetable oils and extracts, compound preparations and single-ingredient formulations, and biological products. This system effectively reflects the current status of veterinary drug production and use in China.

　　The 2010 edition of the Veterinary Pharmacopoeia includes a total of 1,829 standards, including pharmaceutical excipients; among these, 609 are new entries, representing an increase of 49.9%. Additionally, 1,128 standards have been revised, achieving a coverage rate of 92.1%. The appendices contain a total of 252 items, with 41 new entries, marking an increase of 19.4%, and 123 items have been revised, resulting in a coverage rate of 41.7%. The Guide to Veterinary Drug Use lists a total of 1,508 veterinary drug varieties, with 466 new entries, representing an increase of 44.7%. The magnitude of the increase in the new edition of the Veterinary Pharmacopoeia is unprecedented, fully reflecting the extensive, painstaking, and meticulous efforts made by the industry in preparing this new edition.

　　 Q: What are the key features of the new edition of the Veterinary Pharmacopoeia in terms of promoting and applying new technologies and methods?

　　 Answer: Building on the previous edition, this edition of the Veterinary Pharmacopoeia actively conducts reviews and references of standard testing methods for veterinary drugs, taking into account the characteristics of chemical pharmaceuticals, traditional Chinese medicines, and biological products as well as the actual conditions of the industry. At the same time, it places great emphasis on gradually aligning with international standards and unifying with national standards, thereby further expanding the application of modern analytical techniques in the standards of the Veterinary Pharmacopoeia. In addition to classical testing methods, this edition has introduced the use of high-performance liquid chromatography (HPLC), gas chromatography (GC), thin-layer chromatography (TLC), and other advanced techniques in the inspection and assay of veterinary drugs. Specifically, HPLC is now used for the identification, inspection, and assay of 143, 229, and 154 chemical pharmaceuticals, respectively—increases of 57, 144, and 63 compared to the 2005 edition. GC is employed for the identification, inspection, and assay of 10, 48, and 17 chemical pharmaceuticals, representing increases of 4, 41, and 6, respectively, over the 2005 edition. Infrared spectrophotometry is applied to the identification of 184 chemical pharmaceuticals, an increase of 44 compared to the 2005 edition. Ultraviolet spectrophotometry is used for identification and inspection of 69 and 86 chemical pharmaceuticals, respectively—increases of 2 and 27 compared to the 2005 edition. TLC is used for the identification of 59 chemical pharmaceuticals, up 20 from the 2005 edition, and for inspection purposes, it is applied to 48 chemical pharmaceuticals. In particular, to ensure the quality of veterinary drugs, the number of tests for related substances has been significantly increased. This edition of the Veterinary Pharmacopoeia has undergone extensive revisions and features a substantial increase in the number of included varieties, resulting in marked improvements in both the efficacy and safety of veterinary drugs, and further expanding the application of modern analytical technologies.

　　 Q: Traditional Chinese medicine is China’s traditional medicinal system. What breakthroughs has the new edition of the Pharmacopoeia made in the area of TCM?

　　 Answer: The newly compiled “Guidelines for Veterinary Drug Use (Chinese Herbal Medicine Volume)” is one of the most distinctive and noteworthy highlights—a breakthrough that fills a significant gap. Chinese herbal medicine is a traditional medicinal system unique to China, deeply rooted in its cultural heritage. The new edition of the Veterinary Pharmacopoeia places greater emphasis on the holistic control of Chinese herbal medicine quality, adding 373 standards for Chinese herbal slices and 10 standards for Chinese herbal extracts. This development partially addresses the longstanding issues of limited varieties and lagging R&D levels in Chinese veterinary medicines, laying a solid foundation for the next steps toward developing eco-friendly and green veterinary drugs, popularizing the application of Chinese veterinary medicines, promoting scientific and technological progress in this field, and enhancing both the production and quality standards of Chinese veterinary medicines. Meanwhile, the completion of the “Guidelines for Veterinary Drug Use (Chinese Herbal Medicine Volume)” will undoubtedly transform the previous situation in which specialized terminology was difficult to understand and hindered proper usage. It holds great significance for promoting China’s traditional veterinary medicine and advancing the industrialization of Chinese veterinary medicines in our country.

　　 Q: How can we effectively implement the new edition of the Veterinary Pharmacopoeia? Specifically, what steps should veterinary drug manufacturers take?

　　 Answer: The Chinese Veterinary Pharmacopoeia is a national code designed to ensure the quality of veterinary drugs and the safety of animal products. The standards included in the Pharmacopoeia represent the most basic requirements set by the state for each veterinary drug product and serve as the legally binding guidelines that veterinary drug manufacturers must follow. To ensure the smooth implementation of the 2010 edition of the Chinese Veterinary Pharmacopoeia, our ministry issued Announcement No. 1592 on May 31 of this year, setting forth relevant provisions and requiring veterinary regulatory authorities at all levels to actively organize, implement, and supervise the new edition of the Pharmacopoeia. They are also urged to intensify publicity, training, and guidance efforts. For veterinary drug manufacturers, it is crucial that each company attaches great importance to the implementation of the new Pharmacopoeia. Companies should carefully review their existing product lines against the standards outlined in the new edition. Wherever there are changes in quality standards, companies must promptly make corresponding improvements to their production processes, enhance their testing techniques, and revise their packaging, labels, and package inserts. It is particularly important to note that this edition of the Pharmacopoeia significantly expands the coverage of pharmaceutical excipient standards—from 9 varieties in the previous edition to 132 varieties. Henceforth, veterinary drug manufacturers must procure and use pharmaceutical excipients that meet the specified standards. Whether or not these excipients comply with the requirements will also become a key component of GMP inspections and acceptance checks for veterinary drugs. Therefore, companies should promptly organize training sessions for employees in relevant positions, such as quality control and production, to ensure they thoroughly understand the quality requirements and testing techniques stipulated in the new Pharmacopoeia and thereby guarantee the safety and quality of their products.

　　Regarding the transition between the old and new Veterinary Pharmacopoeias, our Ministry has already provided clear guidelines in Announcement No. 1592. There are three key provisions that enterprises must understand: First, veterinary drug products manufactured before July 1, 2011, may continue to be inspected according to the original veterinary drug standards until their expiration dates; second, for veterinary drug labels and package inserts printed before July 1, 2011, and whose standards for the same product remain unchanged as listed in the "Chinese Veterinary Pharmacopoeia (2010 Edition)," veterinary drug manufacturers may independently revise the "Implementation Standard" section and continue using these labels and instructions until June 30, 2012; third, starting from July 1, 2011, applications for approval numbers of veterinary drug products containing substances listed in the "Chinese Veterinary Pharmacopoeia (2010 Edition)" must explicitly state and comply with the standards set forth in the "Chinese Veterinary Pharmacopoeia (2010 Edition." Applications that do not meet these requirements will not be accepted.