In order to implement the reform spirit of the State Council’s “delegation, regulation, and service”, the Ministry has recently organized spot checks on the issue of veterinary drug production licenses in some provinces. In order to further strengthen the handling of matters concerning the issuance of veterinary drug production licenses, and to ensure that administrative licensing matters can be put down, received, and managed well, the relevant matters are hereby notified as follows.
One, spot check work situation
From November to December 2020, our Ministry organized the China Veterinary Drug Inspection Institute to send 5 inspection teams to Beijing, Shanxi, Heilongjiang, Jiangsu, Zhejiang, Shandong, Henan , Sichuan and other 8 provinces (cities), randomly checked the implementation of the veterinary drug production licenses of 36 veterinary drug manufacturers, and focused on the compliance of the application materials of each enterprise through file verification, on-site inspections, and discussion interviews. , Implementation of licensing procedures, implementation of veterinary drug GMP inspection and acceptance standards, reporting and review of approval information, and implementation of veterinary drug GMP at the production site.
In general, 8 provinces (municipalities) have formulated and announced work procedures for veterinary drug production license matters, handling guidelines, etc., and can carry out licensing in accordance with the prescribed procedures Approval work. Among them, Heilongjiang Province adopts random methods to select experts from the veterinary drug GMP inspector database of the Ministry of Agriculture and Rural Affairs for auditing materials and on-site acceptance to strictly control access; Jiangsu Province and Zhejiang Province implement non-face-to-face examination and approval, and realize the”online application, online processing, Express delivery and electronic filing”; Jiangsu Province continues to consolidate the foundation of technical support, absorbing experts from scientific research institutes as GMP inspectors for veterinary biological products, and a total of 125 provincial inspectors. The random inspection companies reported that after the issuance of the veterinary drug production license was delegated, the communication between the company and the provincial animal husbandry and veterinary authority was faster and more effective, the approval process was simplified, the process time was greatly reduced, costs were saved, and efficiency was improved.
2. The main problems found in spot checks
(1) The technical review is not rigorous enough. The spot check found that the production scope of individual veterinary drug manufacturers approved by Beijing was inconsistent with the actual situation. The spot check found that the three veterinary drug manufacturers belonging to the same group had a combined use of label library, raw and auxiliary material library, finished product library and quality inspection room; individual veterinary drugs in Shanxi Province The production scope and production address listed in the declaration materials of the manufacturer are inconsistent with the inspection and acceptance report; the production scope involved in the on-site inspection conclusions of individual veterinary drug manufacturers in Henan Province is inconsistent with the issued production license.
(2) The enforcement regulations are not strict enough. A spot check found that a veterinary drug manufacturer in Shanxi Province obtained a veterinary drug production license on February 21, 2019. The company’s newly built powder, powder, and premix production workshops did not meet the seamless connection of automated and closed production systems. Request, did not implement the provisions of the Ministry of Agriculture Announcement No. 1708. Shanxi Province conducted veterinary drug GMP inspection and acceptance on 3 new veterinary drug production enterprises on February 4, 2017, but failed to comply with the”Notice of the General Office of the Ministry of Agriculture on the issuance and decentralization of veterinary drug production licenses” (Agricultural Affairs Office (2015) No. 11) It is required to select a team leader from our veterinary drug GMP inspector database; Zhejiang Province has insufficient time to publicize the veterinary drug GMP inspection and acceptance results of some enterprises, which does not meet the requirements of the Ministry of Agriculture Announcement No. 2262, and some date writing is incorrect.
(3) Veterinary drug GMP inspector management does not meet the requirements. Shanxi Province only uses senior titles as the standard for veterinary drug GMP inspectors. It does not require and examines the professional, experience and technical capabilities, does not divide the inspectors’ professional fields, and does not specify the inspection team leader; when selecting and assigning, it ignores the application company The match between the scope of production and the professional expertise of the inspectors led to the inconsistency of the inspection team leader and inspector’s professional capabilities with the requirements of veterinary drug GMP inspection and acceptance.
(4) The quality of service needs to be improved. Beijing canceled the submission and review of application materials for veterinary drug GMP inspection and acceptance (companies only need to provide application forms to apply for veterinary drug production licenses), greatly increasing the responsibility and pressure of the on-site inspection and acceptance team, and it is difficult to ensure the quality of inspection and acceptance; Jiangsu Province adopts In the way of centralized online publicity and approval of the list of approved enterprises every year, some enterprises have reported that the announcement is relatively late.
(5) The data archiving is not standardized enough. The continuity of archive management and other work in Heilongjiang Province is poor, and the site can only spot-check the approval and archived materials since 2019; some of the archives in Shandong Province lack paper review opinion letters, dispatched inspection and acceptance materials, on-site acceptance notices, and rectification completion approval. Tables, etc.; the filing cabinets in Sichuan Province are placed in the corridors, and some of the filing cabinets are not locked, which does not meet the requirements for file storage.
In addition, during the on-site inspection of veterinary drug manufacturers, the spot check team also found that some manufacturers have problems such as non-standard implementation of veterinary drug GMP and product quality management. Ministry of Animal Husbandry and Veterinary Bureau will transfer to relevant provinces to implement rectification within a time limit.
3. Further strengthen the approval process
(1) Make every effort to rectify problems within a deadline. The above notified provinces should carefully formulate the rectification work plan against the problems found in random inspections and verifications, establish item by item accounts, clarify the time limit for rectification, and report the rectification to the Animal Husbandry and Veterinary Bureau of the Ministry before April 30, 2021; especially for In cases where the implementation of the regulations is not strict, the relevant enterprises shall be strictly required to make corrections within a time limit, and if they fail to make corrections within the time limit, their veterinary drug production licenses shall be revoked in a timely manner. It is necessary to organize a”look back” to find and solve problems in time.
(2) Carry out a comprehensive investigation by analogy. All provincial-level animal husbandry and veterinary departments should attach great importance and earnestly perform their duties and functions in handling the issuance of veterinary drug production licenses. They should learn from the related problems found in random inspections, draw lessons from one another, and conduct comprehensive investigations to prevent similar problems from occurring. It is necessary to rectify problems more seriously, establish guidance, strict rules, and suppress responsibilities, to ensure that one standard is checked to the end, and a ruler is measured to the end, so as to effectively improve handling efficiency and work effectiveness.
(3) Improve and improve the licensing system. All provincial-level animal husbandry and veterinary departments shall strictly follow the work procedures and examination and approval service standards to carry out the issuance of veterinary drug production licenses. Strengthen veterinary drug regulatory knowledge training for veterinary drug approval personnel, improve the technical review system for application materials, ensure that administrative licenses meet the requirements of relevant veterinary drug management regulations, and ensure the quality of veterinary drug production license approval work.
(4) Continue to strengthen the management of veterinary drug GMP inspectors. All provincial-level animal husbandry and veterinary departments should strengthen the construction of veterinary drug GMP inspectors and veterinary drug regulatory personnel, earnestly organize the selection, assessment and management of provincial veterinary drug GMP inspectors, and strictly control the entry threshold of inspectors. It is necessary to strengthen the implementation of the”Veterinary Drug Production Quality Management Regulations (Revised in 2020)”, strengthen the business training of veterinary drug GMP inspectors, especially inspection team leaders, to ensure that relevant personnel fully and accurately grasp the relevant GMP regulations, policies and technical standards, and to ensure that the new version of veterinary drug GMP Check the scientific and fairness of the acceptance work.
(5) Effectively fulfill the responsibility of territorial supervision of veterinary drugs. Animal husbandry and veterinary departments at all levels must strictly implement territorial management responsibilities, and earnestly implement local regulatory responsibilities for veterinary drug manufacturers. It is necessary to increase inspection efforts and expand inspection coverage by means of unannounced inspections, supervision and random inspections. For violations of laws and regulations discovered during inspections, the evidence should be fixed at the first time, and the case should be filed and dealt with in a timely manner, so as to effectively improve the efficiency of supervision and law enforcement.
Ministry of Agriculture and Rural Affairs Office
February 26, 2021