In order to further strengthen the review of vet®erinary drugs and improve the efficiency of the r↓₩eview work, the Ministr¶₩♠y of Agriculture has revised ☆↔σthe "Veterinary Drug Registration Revie<Ωw work Procedure" and is₹∑γ♥sued it, which will take effect δ₹∑ from the date of release, aαδ ★nd the original "Veterinary Drug Re←♦gistration Review WorΩ∞≠k Procedure" (Agricultural medicine (≤•2005) No. 17) will be abolished at the same tim♥≈∏e.
Procedures of veterinary drug registration revi✔¥↓ew
In order to standardize the registration and"× ★ review of veterinary drugs, this work↔≈←≥ procedure is formulated in accordance wit☆✔±h the relevant provisions of the Regulations on γΩthe Administration of Veterinarπ♣y Drugs and the Measures f &or 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 registrati"<on review.
(2) The Veterinary Drug Evaluation Center of th★☆e Ministry of Agriculture (herei ≈&nafter referred to as the "Evaluation Centγ∞φer") is responsible for the technical re∞®♥view and technical rev↔≠iew of the application for vet✘☆erinary drug registration, on-site verification×☆• of veterinary drug registration and the archivalγβ preservation of reviλ∏ew materials.
(3) The China Veterinary Drug Supervis♣<ion Institute (herein∑•Ω after referred to as th♣↓e "China Veterinary Drug Su∑φ≥×pervision Institute") is resp∑σ εonsible for organizing the revie♥≥w and inspection of registe₩≤red veterinary drugs, issuing the review ≤$<and inspection report, and putting forward revieδ↓ w opinions on whether the draft quality sta&≠ndards can control the quality of ÷×products and whether the in →spection methods are operable; Responsibφle for the technical data review of €♠standard substances and bacteria (poison, in±☆σ sect) species inspection.
(4) Veterinary drug review experts are respo©∑€nsible for putting forward re©δview opinions on the safety, effectiveness and q♣'πuality control of vet®erinary drugs applied for registration, a≠δ₩nd participate in the research and discussion €$♦on the management and technical ∞↓σstandards of veterinary dr↔>↓ug registration review.
2. Review working methods
(1) General review. Con≥←φ ventional veterinary drug rγ±egistration adopts the g©πλ"eneral review method. For<♦ specific review wor↕•kflow and requirements, see "II§Ω•₩I. General Review Workflowπ¥ and Requirements".
(2) Priority review. Veter"'•inary drugs that meet the f±γ∞<ollowing conditions can be evalu÷σ↑ated in a priority manner: va©>¥ccines and diagnostic prod©₩♣¥ucts that can achieve dif&δ≥ferential diagnosis ₩¶γ★of 16 diseases identified as domestic prioriαγ↑₽ties in the National Me∏☆₩dium and Long Term A♥•βnimal Disease Control Plan (2016-2020); Veteri• ↕nary drugs for horse racinλ☆βπg and pets, as well as for specialγ'↔ economic animals, bees, silkworms and aquacul∞$€ture, which are urgently needed in cli÷♥♥nic and in short supply in the π≈≤market; Innovative veterinary chemicals tha$♥πt are not marketed in or outside China; The epide ←✔mic prevention of major animal diseases is in u★←↑<rgent need of veterinary drugs. The evaluatioβ™©₽n center will arrange the evaluation as soon a&βs possible, and report theΩ≠♥± evaluation opinions and c§'onclusions as soon as possible; The first t↕€ime to arrange a review i±₩π↔nspection. However, the technical requirement♠≤s of the review are not reduced, the ₹±review steps are not reduced, ☆απand the review process is t≤δhe same as the general review.
(3) Emergency evaluation. The Ministry of Agricuα∏≈lture may initiate emergency evaluation methods ∑>for veterinary drugs required for emergency≠±♦÷ treatment of sudden major an✘ε€★imal epidemics. The evaluation center shall carε↔ry out emergency evaluation in accordanc"÷e with the requirements of the V↔•eterinary Bureau of t₽♣he Ministry of Agriculture, focusing on the ×&safety, effectiveness≤✔< and quality control of veterinary drugs, and no≠₩n-critical data may not be provid±≠>€ed for the time being. If the evaluation suggesσλ&®tions can be used in an emergency, the₩∞ Veterinary Bureau of∏"ε the Ministry of Agriculture shall put forward✔×λ audit opinions according to the evaluaπ♦tion opinions of the☆δ∑ evaluation center, and issue te>¥chnical standard doc×★uments after approval by the lead ∑↑₩ers of the department in cπ₹harge. Relevant veterinary drug manufacturers app∑•✘ly for temporary veterinary drug produc•∏t approval numbers in acc∑ ordance with the provisions ofσ§♥ the Measures for the Adminis>∑tration of Veterinary Drug Produc±↑t Approval Numbers.
(4) Record review. Accordiσ←ng to the needs of animal epidemic prevention,¶♠ the change of bacteria ( •₹ viruses) used in the production of compulsor λ✔y immunization vaccines recommended b<π y the National Veterinary reference laborat¥₽®ory shall be recorded and reviewed. F ↓★•or details of the review process and requir ¥"ements, see the "Highly Pathogeσ★λnic Avian Influenza and foot-and-mouth disease v ♠accine Production virus C∑>hange filing Procedure ∞s" and change technical data re↓σquirements.
Iii. General review wo≈☆γrkflow and requirements
(1) Receipt and acceptance of declarati↔∑≤≥on materials. The Administrative ap♦¥×σproval Office hall of the Ministry o÷☆f Agriculture (hereinafter ref ∞erred to as the "Office hall") receives v ™↕eterinary drug registratio₩₩Ωn application data. In acc∏'≥↓ordance with the work∑≥ ing conditions of the Mini®β"stry of Agriculture's ad€βministrative approval ser↑↓×vice guidelines and the relevant$↔₩∏ requirements of veterinary drug registration da←σ≤ta, the evaluation center conduα®↕cts a formal review of the received declaration dλ&ata, and reports the formal ∑≈λ®review comments to the veteri™>nary Bureau and the off±' ice hall.
The office hall shall handle the formalities of→ acceptance or rejection accor ↔ding to the formal review opinions, and not < ify the applicant and the evalu↑•∑ation center in writing.
(2) Technical review of application data. The✘ evaluation center shall organize↕∑♣ the technical evaluation of ★≠"the accepted applicatδ☆ion materials. The evalua$™tion center should listen to tφ©σγhe opinions of the expe✘↓♠₽rt group before putti¥¥✘©ng forward the final opinions and concβ÷✘lusions, generally adopting t¶€↔he review meeting method, but also adopting th₹♦e letter review, online review and♣>£ other methods, and all the review experts׶₽φ should put forward written review opinions. Whe& n the evaluation center adopts the review me<©↔eting method to listen to the opinions o✔'≥f the expert group, it may hold a re₽×★view meeting in the form of "prelimina♠★ry review + review". Before e>$≥€ach veterinary drug review meeting, exp∑>erts participating in÷§© the review meeting should be selected from t €he expert database in accordance with the ex' ≤pert selection principles formulated by the ≥&review center, and the grou∏&¶αp leader and the chief review ©≈δ&expert should be determined. For vφ<•'arieties involving different profes←±sions or varieties with difficul→©♣πt problems, experts from relevant professionβ ™¶al groups of different profes÷€sions can be organized to joiδ"₹ntly review.
If necessary, the evaluation Center€≈ may temporarily hire exper€γts outside the expert pool to partic₽πipate in the evaluation meeting₩'δ.
1. Preliminary review. The evaluation center shaε≤ll organize a preliminary examination meeting ≤∏for the accepted declaration materiaε'∑∞ls. There are general×$δ×ly no less than 10 experts attending÷♦↕ each review meeting. The review meeting is cha≤✔Ω♠ired by the group leader, a ©'♣nd the organizer is &♦↓responsible for introducing the accepta♥≠↓nce and review process of products; No less tᶩ$han 2 lead experts are selec¥φλσted for each product, and the lead experts are re♦βαsponsible for introducing the information of th₩¥×e declaration in detail. The preliminary examinat±✘γ÷ion committee shall review all the application ♦& data in accordance with the requirements of vet¶↕Ω☆erinary drug registration data γ and relevant guiding prin±×ciples, put forward comprehensive review opinions♠∑ש as far as possible at one tiλ♦γme, and decide whether to φ'₩conduct review inspection and whether on-site→γ↔ verification is necessary. If the ne"←w veterinary drug applied for is a biological proββduct, it may, if necessary, put forw×ard the requirements for the insp<₽∑®ection of bacteria (toxins, insects) used in pro♥¶♣duction. At the end of the meeting, eac∞§¥h review expert puts forward per∑αλsonal opinions, and the lead review expert♠≈φ summarizes the review↕" opinions, and the review expert δ₹group reviews the revie± ≈w opinions, and votes if necessary, and fin₽ally puts forward the±♥ review opinions of the review§↔ meeting according to the review and votinα←©g results. The Accreditation Centre may arrange<γπ★ exchanges between registered applicants ★>•at the accreditation ♥•"★meeting according to their application♠✘©.
2. Review. The evaluation center shall €γorganize a review meeting fo♦π↔≈r the products that need to ≈≠"be reviewed after completing tα∏≤he veterinary drug review ☆₹inspection. The meeting is cha←φ✔ ired by the group leader, the director φ™reports the preliminary review ≠¶₽opinions, if necessary, the supervision ≈≥α institute introduces the product∏Ω¶ quality standard review op∑¥inions, and the chief review ex♠₩pert introduces the review in¶♠formation. There are usually no le'↕£®ss than 12 experts attending the con•♣→ference. At the end of the review meeting, each r₩↕✘eview expert puts fo←>₽★rward personal opinions, an♥ ≥εd the lead review expeδ<rt summarizes the review opinions, and tλ€÷he review expert group review♥♣¥s the review opinions, and votes, and finally pu↑★ ts forward the review opinions of t ¶he review meeting according to±•₽ the review and voting results.
3. Voting method. Voting¥₽ shall be conducted by secret ballotαββ' for "agree" or "disagr∑α "ee" on the review opinions of the₽¥ meeting, and the expert who >votes "disagree" shall giv♠∏e specific reasons for the disagrδ€♣eement. When the revδπ©iew meeting votes on the review opinion••₽©s, the organizer shall invoice and tall®₹♣y the votes, and a review expert shall¶π supervise the votes§•. If more than 2/3 of the partε§icipating experts agree with the γ review comments, the review comments shall≈β be deemed valid.
If the review meeting can±™®Ωnot reach a unanimous review opinion, a secret v§φ ote can be held on whether t ∏≥♠o agree to continue the review of the product an∏÷σd indicate the specific reasons. If more than β∞↔✘2/3 of the participating expert★✔ ✔s agree, the review will continue, otherwise it£★♠ is recommended to withdraw.λ™ The review opinions and voting results of the ¶λ≈←review meeting shall be recorded in the f '§orm of review report.
4. Final appeal. The evaluation center shall r₩∞•eview the evaluation ₽♠opinions put forward by the ev♣$aluation meeting and put f<<orward the final opinio↔↕♣ns and conclusions of the technical evaluatioε¶n and submit them to the Veterinary Bure↓λ®∏au of the Ministry of Agriculture. Tα≈₩he working mode shall b→βe determined by the evaluation center according t®σ o the needs.
5. Relevant requirements. The evalua ♣λ→tion center should strengthen its internπφλ<al management, improve the working mechani≈∞sm of veterinary drug registration review and inδβ×spection, and refine the job respons&¶"ibilities and requirements of the director of vet×♠♥erinary drug registration review. Review exper§±ts, chief review experts and group leaders s♥✔hould perform their duties and oblig↔←©±ations in accordance witα>h the relevant provisions±↔® of the Measures for the Ma♣↑∞nagement of Veterinary Drug Review Exper≥₹φ>ts of the Ministry of Agriculture, keep the b¥φβusiness secrets of the reporting unit,✘•≥ strictly implement the avoidance system, and ★βstrictly abide by the review discipline and int ≈egrity provisions.
(3) Review of veterinary d☆φrug quality standards. If it is necessary to c₽•←₹arry out a review of the qua>∏ε✔lity standards of veterinary drugs during the≥< technical review period, the review∑£∑ center shall notify ↑♠↔the intermediate prison≤↑¥ and the applicant in written foφ♣rm. The applicant shall, within 6 months after re∑¶←ceiving the notice of the review and inspecti¶✔on of the review center, submit γ÷♦βthe samples and relevant materialπγs required for the review and inspection to☆© the China Prison Institu≥♣₽te. According to the review opini≠∏<φons, in accordance with the "Veterinary drug Reε gistration Measures" and other relevant pro"₹visions to carry out veterinary≤★☆✔ drug quality standards review work, and within the prescribed time limit w'±✔ill be the inspection report γ±to the Ministry of Agriculture veter¶±§inary Bureau, the quality standard review cλ♥omments to the review center. If the C$¶↔αhinese prison does not receive the review s&"≈ample or relevant information or inco×¥mplete materials within 6 months after recei€€ving the review inspection notic↑γ↑↕e from the review center, it shall explain the s±₹pecific situation to th'δ₽e review center, and the review center shall au♥£tomatically withdraw the registration $® application according to the instructions.
(4) Supplementary information andπ→ε≈ submission of relevant substances, etc.∞δ$ If supplementary information, confir♥ε∏mation of technical st♠←≈andards, submission of standard'★ substances and bacter♥αia (poison, insect) sp≤≈εecies and cells are require₽π→←d during the technical rev ↓♥iew, the review Center shall n♦∏> otify the applicant in writing. The appl↑£icant shall supplemenγβ↕•t the materials, confirm the technical st× π'andards, and submit the standard materialsσ•< to the prison in accordance wΩ•₹ith the evaluation opi€₹nions. The applicant for registration oΩ€Ω₽f veterinary biological pr↔©☆₽oducts shall go through the proced䱶ures for receiving aε✔nd storing bacteria (poison, insect) species, celσ ≈ls and other related materials in the China Ve↑¶₩terinary Microbial Culture Preservation Manag©→ement Center, and submit the r €≤esults to the Evaluation center.
(5) Examination and approval. The V®☆eterinary Bureau of the Ministry of Agriculture±♣☆ put forward the approval pl→λan according to the final opinions and conclus≤→ions of the technical review center and the con₽>clusion of the review and inspection of the pris∑¶λon by the collective delα"iberation of the Bureau. If it is propos☆£λ∑ed to be approved, it shall be submitted to the≤× leader of the department in charge foΩ©πβr examination and approval, a•♣∏₽nd according to the appro÷ ∏val opinions of the leader of ✘ the department in charge, i↕±t shall issue a public←$₩ announcement and make a registration certifi€'±δcate; If the proposal is not appr₩✘γoved, the director of the Veterin∑≈ary Bureau of the Ministry of Agriculture shall♦∞∞ examine and sign it.
(6) Completion. The offi÷→≠≤ce hall shall conclu↓∞¥de the examination a↓™nd approval according to ←€the conclusion, and notify the applicant &≠λ£in writing. The working methods of techni≤∑cal evaluation for emergency evaluationε' and archival review shall be carried out✔÷ in accordance with general review.
Iv. Review suspension time
If it is necessary to suspend thδ€₩e review time during the Ωreview process, the following procedures shφ♠ all be followed.
(1) When the applicant needs♦σ™π to supplement the information and submit th'☆e sample for review, the standard m→←αaterial for testing and th★©™e raw materials for preparing the standa←™rd material and related informatioδ πn, the evaluation cente×±$r shall report to the Veterinary Bureau of theσ±← Ministry of Agriculture, a₽©↕nd submit an application to the Admini≤↓strative examination and Approval Offi$≥§ce of the Ministry of ♦$÷ Agriculture (hereinafter referred to ® ♠≤as the "examination and A₹'pproval Office") to stop the evσ÷aluation and timing Ω✔® application, and the examination and≥ approval office shall start the applicant's su ♦pplementary information timing. ®™↓λAfter receiving supplementarγδ₽♣y information, review of ↓& test samples, standard materials for tesλ✘$™ting, raw materials for preparing₹$☆ standard materials and related informa←★<₹tion, the evaluation Center shall timelσ••y submit an application to resume the ev©•©×aluation time.
(2) When the applicant♣✔ needs to confirm the quality standard®®αs, labels and instructions, the evaluat≠£ ion center shall rep≤☆ort to the Veterinary Bureau of the Minist↓φφ≥ry of Agriculture, sλ™<♦ubmit an application to th€♥e approval office to stop the evaluation of₽∑ the timing, and the approva✔§₽l office will start the applicant's supplement←Ωary information timing. ♠ ¥"After receiving the applicant₹↓'s confirmation letter, the evaluation$♥↔ Center shall timely submit an applicati&¶₩on for the resumption of the evalγ ¥uation time.
(3) During the registration of ↕±↑σimported veterinary drugs,♦©"& when the applicant needs to conduct clinical ve↓δrification tests or ve↔♠♣∏terinary drug residue dete✔✘<ction method verification ← αtests in China, the evaluation center shall rα∞¥♣eport to the Veterin₽₹♦∏ary Bureau of the Ministry of Agricult'✘δure, submit an application to the approva♣∞₽l office to stop the review and tim∞ ∞γing, and the approval office will start the≥₹ applicant's supplementary information timing.§"∑ After receiving the a™δ✘pplicant's clinical verification te←↑✔st results report or veterinar™÷α§y drug residue test method ×¥verification test report, the evaluation center§₩♦ shall timely submit an applicat←α ₹ion for the resumpti↓$on of the evaluation time.★☆ ★
(4) If on-site verification i☆↔s required, the review time shall be → α suspended. The evaluation center shall r©γeport to the Veterinary Bureau of ®γ♦☆the Ministry of Agriculture and apply tσλσ₩o the approval Office for stopping the evalu÷≥ation time. The evaluation Cente'σ•¥r shall organize and complete♦₹©< the on-site verification within 40 work↕∞ing days. After the cβλπompletion of the on-site ♦↕verification, the evaluatio✔βn center shall timely submit an a∑γ¶pplication for the resumptio&×∞§n of the evaluation time.
(5) If the timing needs to→φ→ be stopped due to factors such as t£he adjustment of the animal↕γ epidemic prevention policy or the ™♠veterinary drug management §∞♥policy, the Veterinary Bureau of th≈♦e Ministry of Agriculture shall send a let∏<∑ter to the General Office ±∏§of the Ministry of Agr∞δ÷©iculture to stop the rev"₽iew of the timing and★$→ clearly stop the timing.