On 26 November 2020, the Ministry of Agriculture and Rural Affairs of the People’s Republic of China (“MOA”) promulgated the Veterinary Pharmacopoeia of the People's Republic of China (2020 Edition) (the “New Veterinary Pharmacopoeia”), which will take effect on 1 July 2021. According to the Announcement No. 363 of the MOA on 26 November 2020 (the “Announcement”), the New Veterinary Pharmacopoeia is formulated according to the Regulation on the Administration of the Veterinary Drugs, effective on 27 March 2020, and it is the statutory technical standards which must be followed in the development, production (import), distribution, use, supervision and management of veterinary drugs in the People’s Republic of China (the “PRC”). Veterinary drug manufacturing enterprises are required to implement the New Veterinary Pharmacopoeia to continuously improve the quality control level of veterinary drugs.
1. Legislative Highlights of the New Veterinary Pharmacopoeia
The New Veterinary Pharmacopoeia is divided into 3 parts, including veterinary chemicals, traditional Chinese veterinary medicines and veterinary biological products. In total, it contains 3 legends, 1621 varieties and 302 appendices. Compared with the previous 5 editions of veterinary pharmacopeia, this new edition has more innovations, strengthened guidance on safe medication, and tightened the risk control of veterinary drug quality.
a) The New Veterinary Pharmacopoeia highlights the needs of the veterinary industry and increases dedicated varieties. Under the premise of ensuring safety, the New Veterinary Pharmacopoeia expands the range of veterinary drug varieties, focuses on veterinary specialty formulations, meets the needs of veterinary clinical drugs, reflects the needs of veterinary drug production and testing, and adds 49 new varieties of veterinary drugs, including pet drugs and breast injections, etc.
b) The New Veterinary Pharmacopoeia highlights technical research, and the level of standards formulation has been significantly improved. It adopts advanced veterinary drugs and pharmaceutical technologies from overseas, which improves the specificity, sensitivity and accuracy of detection methods.
c) The New Veterinary Pharmacopoeia highlights safety requirements and further improves quality supervision capabilities. The revised appendix to the New Veterinary Pharmacopoeia completes the overall requirements for the safety and safety inspection of veterinary drugs. Besides, the inspection and control of toxic or easily mixed ingredients are added to the main context.
d) The New Veterinary Pharmacopoeia realizes the effective connection of veterinary drug use management with the food safety supervision.
e) The New Veterinary Pharmacopoeia improves risk management measures. It has removed those veterinary drugs which have or may have safety risks, or outdated technologies, such as amethyst and caffeine, etc.
2. Implementation during the Transitional Period
a) According to the Announcement, after the New Veterinary Pharmacopoeia will come into effect, the 2015 Edition of the Veterinary Pharmacopoeia of the PRC, the Veterinary Drug Quality Standards (2017 Edition) and quality standards of veterinary drugs of the same species contained and promulgated by MOA shall be abolished accordingly.
b) For those varieties of veterinary drugs included in the New Veterinary Pharmacopoeia but the specification for preparation of such veterinary drugs is not included (except for those that have been abolished), quality standards of such veterinary drugs shall be implemented in accordance with the requirements under the New Veterinary Pharmacopoeia whilst the specifications for preparation shall be implemented in accordance with relevant original approval documents.
c) The following standards shall continue to be valid, but shall be implemented in accordance with relevant general requirements of the New Veterinary Pharmacopoeia: (1) national standards for veterinary drugs that are not included in the New Veterinary Pharmacopoeia and have not been abolished; and (2) national standards for the change of registration of veterinary drugs that have been approved and announced but are not included in the New Veterinary Pharmacopoeia.
d) According to the Regulation on the Administration of the Veterinary Drugs, a veterinary drug manufacturer shall obtain an approval number of products issued by the veterinary administrative department under the State Council. According to the Announcement, starting from 1 July 2021, the enterprises which apply for the approval number of a veterinary drug product as well as veterinary drug inspection agencies shall conduct sample inspection in accordance with the quality standards of the New Veterinary Pharmacopoeia. The wording "PRC Veterinary Pharmacopoeia (2020 Edition) Quality Standards" shall be indicated on the inspection report of such veterinary drug. As to any prior applications, the implementation standards indicated on the veterinary drug inspection report can be either the original veterinary drug quality standards or the "PRC Veterinary Pharmacopoeia (2020 Edition) Quality Standards".
e) Veterinary drugs produced on or before 30 June 2021 can be tested and inspected according to the original veterinary drug standards and circulated for use within the validity period of such drugs.
f) If the label and instructions of a veterinary drug which is included in the New Veterinary Pharmacopeia and which has obtained the approval number on or before 30 June 2021 do not meet the template requirements of the New Veterinary Pharmacopeia, the veterinary drug manufacturer shall modify the label and instructions according to such template requirements, print and label new labels and instructions; however, it is permittable to continue using the original labels and instructions on the veterinary drug until 31 December 2021. The veterinary drugs produced before 31 December 2021 which bear the original labels and instructions can still be circulated and used within the validity period of such veterinary drugs.
g) For any application of the approval number of a veterinary drug which is included in the New Veterinary Pharmacopeia and for any inspection of the veterinary drug which is conducted according to the original quality standards before 30 June 2021, if such application is rejected for reapplication, the applicant is still allowed to submit the original inspection report as one of the re-application documents before 30 June 2022.