Ministry of Agriculture issued "Veterinary Drug Registration Review Procedures"

In order to further strengthen the review of veterinary drugs and improve the efficiency of the review work, the Ministry of Agriculture has revised the "Veterinary Drug Registration Review work Procedure" and issued it, which will take effect from the date of release, and the original "Veterinary Drug Registration Review Work Procedure" (Agricultural medicine (2005) No. 17) will be abolished at the same time.

Procedures of veterinary drug registration review

In order to standardize the registration and review of veterinary drugs, this work procedure is formulated in accordance with the relevant provisions of the Regulations on the Administration of Veterinary Drugs and the Measures for the Registration of Veterinary Drugs.

1. Division of responsibilities

(1) The Veterinary Bureau of the Ministry of Agriculture shall be in charge of the national veterinary drug registration review.

(2) The Veterinary Drug Evaluation Center of the Ministry of Agriculture (hereinafter referred to as the "Evaluation Center") is responsible for the technical review and technical review of the application for veterinary drug registration, on-site verification of veterinary drug registration and the archival preservation of review materials.

(3) The China Veterinary Drug Supervision Institute (hereinafter referred to as the "China Veterinary Drug Supervision Institute") is responsible for organizing the review and inspection of registered veterinary drugs, issuing the review and inspection report, and putting forward review opinions on whether the draft quality standards can control the quality of products and whether the inspection methods are operable; Responsible for the technical data review of standard substances and bacteria (poison, insect) species inspection.

(4) Veterinary drug review experts are responsible for putting forward review opinions on the safety, effectiveness and quality control of veterinary drugs applied for registration, and participate in the research and discussion on the management and technical standards of veterinary drug registration review.

2. Review working methods

(1) General review. Conventional veterinary drug registration adopts the general review method. For specific review workflow and requirements, see "III. General Review Workflow and Requirements".

(2) Priority review. Veterinary drugs that meet the following conditions can be evaluated in a priority manner: vaccines and diagnostic products that can achieve differential diagnosis of 16 diseases identified as domestic priorities in the National Medium and Long Term Animal Disease Control Plan (2016-2020); Veterinary drugs for horse racing and pets, as well as for special economic animals, bees, silkworms and aquaculture, which are urgently needed in clinic and in short supply in the market; Innovative veterinary chemicals that are not marketed in or outside China; The epidemic prevention of major animal diseases is in urgent need of veterinary drugs. The evaluation center will arrange the evaluation as soon as possible, and report the evaluation opinions and conclusions as soon as possible; The first time to arrange a review inspection. However, the technical requirements of the review are not reduced, the review steps are not reduced, and the review process is the same as the general review.

(3) Emergency evaluation. The Ministry of Agriculture may initiate emergency evaluation methods for veterinary drugs required for emergency treatment of sudden major animal epidemics. The evaluation center shall carry out emergency evaluation in accordance with the requirements of the Veterinary Bureau of the Ministry of Agriculture, focusing on the safety, effectiveness and quality control of veterinary drugs, and non-critical data may not be provided for the time being. If the evaluation suggestions can be used in an emergency, the Veterinary Bureau of the Ministry of Agriculture shall put forward audit opinions according to the evaluation opinions of the evaluation center, and issue technical standard documents after approval by the leaders of the department in charge. Relevant veterinary drug manufacturers apply for temporary veterinary drug product approval numbers in accordance with the provisions of the Measures for the Administration of Veterinary Drug Product Approval Numbers.

(4) Record review. According to the needs of animal epidemic prevention, the change of bacteria (viruses) used in the production of compulsory immunization vaccines recommended by the National Veterinary reference laboratory shall be recorded and reviewed. For details of the review process and requirements, see the "Highly Pathogenic Avian Influenza and foot-and-mouth disease vaccine Production virus Change filing Procedures" and change technical data requirements.

Iii. General review workflow and requirements

(1) Receipt and acceptance of declaration materials. The Administrative approval Office hall of the Ministry of Agriculture (hereinafter referred to as the "Office hall") receives veterinary drug registration application data. In accordance with the working conditions of the Ministry of Agriculture's administrative approval service guidelines and the relevant requirements of veterinary drug registration data, the evaluation center conducts a formal review of the received declaration data, and reports the formal review comments to the veterinary Bureau and the office hall.

The office hall shall handle the formalities of acceptance or rejection according to the formal review opinions, and notify the applicant and the evaluation center in writing.

(2) Technical review of application data. The evaluation center shall organize the technical evaluation of the accepted application materials. The evaluation center should listen to the opinions of the expert group before putting forward the final opinions and conclusions, generally adopting the review meeting method, but also adopting the letter review, online review and other methods, and all the review experts should put forward written review opinions. When the evaluation center adopts the review meeting method to listen to the opinions of the expert group, it may hold a review meeting in the form of "preliminary review + review". Before each veterinary drug review meeting, experts participating in the review meeting should be selected from the expert database in accordance with the expert selection principles formulated by the review center, and the group leader and the chief review expert should be determined. For varieties involving different professions or varieties with difficult problems, experts from relevant professional groups of different professions can be organized to jointly review.

If necessary, the evaluation Center may temporarily hire experts outside the expert pool to participate in the evaluation meeting.

1. Preliminary review. The evaluation center shall organize a preliminary examination meeting for the accepted declaration materials. There are generally no less than 10 experts attending each review meeting. The review meeting is chaired by the group leader, and the organizer is responsible for introducing the acceptance and review process of products; No less than 2 lead experts are selected for each product, and the lead experts are responsible for introducing the information of the declaration in detail. The preliminary examination committee shall review all the application data in accordance with the requirements of veterinary drug registration data and relevant guiding principles, put forward comprehensive review opinions as far as possible at one time, and decide whether to conduct review inspection and whether on-site verification is necessary. If the new veterinary drug applied for is a biological product, it may, if necessary, put forward the requirements for the inspection of bacteria (toxins, insects) used in production. At the end of the meeting, each review expert puts forward personal opinions, and the lead review expert summarizes the review opinions, and the review expert group reviews the review opinions, and votes if necessary, and finally puts forward the review opinions of the review meeting according to the review and voting results. The Accreditation Centre may arrange exchanges between registered applicants at the accreditation meeting according to their application.

2. Review. The evaluation center shall organize a review meeting for the products that need to be reviewed after completing the veterinary drug review inspection. The meeting is chaired by the group leader, the director reports the preliminary review opinions, if necessary, the supervision institute introduces the product quality standard review opinions, and the chief review expert introduces the review information. There are usually no less than 12 experts attending the conference. At the end of the review meeting, each review expert puts forward personal opinions, and the lead review expert summarizes the review opinions, and the review expert group reviews the review opinions, and votes, and finally puts forward the review opinions of the review meeting according to the review and voting results.

3. Voting method. Voting shall be conducted by secret ballot for "agree" or "disagree" on the review opinions of the meeting, and the expert who votes "disagree" shall give specific reasons for the disagreement. When the review meeting votes on the review opinions, the organizer shall invoice and tally the votes, and a review expert shall supervise the votes. If more than 2/3 of the participating experts agree with the review comments, the review comments shall be deemed valid.

If the review meeting cannot reach a unanimous review opinion, a secret vote can be held on whether to agree to continue the review of the product and indicate the specific reasons. If more than 2/3 of the participating experts agree, the review will continue, otherwise it is recommended to withdraw. The review opinions and voting results of the review meeting shall be recorded in the form of review report.

4. Final appeal. The evaluation center shall review the evaluation opinions put forward by the evaluation meeting and put forward the final opinions and conclusions of the technical evaluation and submit them to the Veterinary Bureau of the Ministry of Agriculture. The working mode shall be determined by the evaluation center according to the needs.

5. Relevant requirements. The evaluation center should strengthen its internal management, improve the working mechanism of veterinary drug registration review and inspection, and refine the job responsibilities and requirements of the director of veterinary drug registration review. Review experts, chief review experts and group leaders should perform their duties and obligations in accordance with the relevant provisions of the Measures for the Management of Veterinary Drug Review Experts of the Ministry of Agriculture, keep the business secrets of the reporting unit, strictly implement the avoidance system, and strictly abide by the review discipline and integrity provisions.

(3) Review of veterinary drug quality standards. If it is necessary to carry out a review of the quality standards of veterinary drugs during the technical review period, the review center shall notify the intermediate prison and the applicant in written form. The applicant shall, within 6 months after receiving the notice of the review and inspection of the review center, submit the samples and relevant materials required for the review and inspection to the China Prison Institute. According to the review opinions, in accordance with the "Veterinary drug Registration Measures" and other relevant provisions to carry out veterinary drug quality standards review work, and within the prescribed time limit will be the inspection report to the Ministry of Agriculture veterinary Bureau, the quality standard review comments to the review center. If the Chinese prison does not receive the review sample or relevant information or incomplete materials within 6 months after receiving the review inspection notice from the review center, it shall explain the specific situation to the review center, and the review center shall automatically withdraw the registration application according to the instructions.

(4) Supplementary information and submission of relevant substances, etc. If supplementary information, confirmation of technical standards, submission of standard substances and bacteria (poison, insect) species and cells are required during the technical review, the review Center shall notify the applicant in writing. The applicant shall supplement the materials, confirm the technical standards, and submit the standard materials to the prison in accordance with the evaluation opinions. The applicant for registration of veterinary biological products shall go through the procedures for receiving and storing bacteria (poison, insect) species, cells and other related materials in the China Veterinary Microbial Culture Preservation Management Center, and submit the results to the Evaluation center.

(5) Examination and approval. The Veterinary Bureau of the Ministry of Agriculture put forward the approval plan according to the final opinions and conclusions of the technical review center and the conclusion of the review and inspection of the prison by the collective deliberation of the Bureau. If it is proposed to be approved, it shall be submitted to the leader of the department in charge for examination and approval, and according to the approval opinions of the leader of the department in charge, it shall issue a public announcement and make a registration certificate; If the proposal is not approved, the director of the Veterinary Bureau of the Ministry of Agriculture shall examine and sign it.

(6) Completion. The office hall shall conclude the examination and approval according to the conclusion, and notify the applicant in writing. The working methods of technical evaluation for emergency evaluation and archival review shall be carried out in accordance with general review.

Iv. Review suspension time

If it is necessary to suspend the review time during the review process, the following procedures shall be followed.

(1) When the applicant needs to supplement the information and submit the sample for review, the standard material for testing and the raw materials for preparing the standard material and related information, the evaluation center shall report to the Veterinary Bureau of the Ministry of Agriculture, and submit an application to the Administrative examination and Approval Office of the Ministry of Agriculture (hereinafter referred to as the "examination and Approval Office") to stop the evaluation and timing application, and the examination and approval office shall start the applicant's supplementary information timing. After receiving supplementary information, review of test samples, standard materials for testing, raw materials for preparing standard materials and related information, the evaluation Center shall timely submit an application to resume the evaluation time.

(2) When the applicant needs to confirm the quality standards, labels and instructions, the evaluation center shall report to the Veterinary Bureau of the Ministry of Agriculture, submit an application to the approval office to stop the evaluation of the timing, and the approval office will start the applicant's supplementary information timing. After receiving the applicant's confirmation letter, the evaluation Center shall timely submit an application for the resumption of the evaluation time.

(3) During the registration of imported veterinary drugs, when the applicant needs to conduct clinical verification tests or veterinary drug residue detection method verification tests in China, the evaluation center shall report to the Veterinary Bureau of the Ministry of Agriculture, submit an application to the approval office to stop the review and timing, and the approval office will start the applicant's supplementary information timing. After receiving the applicant's clinical verification test results report or veterinary drug residue test method verification test report, the evaluation center shall timely submit an application for the resumption of the evaluation time.

(4) If on-site verification is required, the review time shall be suspended. The evaluation center shall report to the Veterinary Bureau of the Ministry of Agriculture and apply to the approval Office for stopping the evaluation time. The evaluation Center shall organize and complete the on-site verification within 40 working days. After the completion of the on-site verification, the evaluation center shall timely submit an application for the resumption of the evaluation time.

(5) If the timing needs to be stopped due to factors such as the adjustment of the animal epidemic prevention policy or the veterinary drug management policy, the Veterinary Bureau of the Ministry of Agriculture shall send a letter to the General Office of the Ministry of Agriculture to stop the review of the timing and clearly stop the timing.