CPMP-Note for guideline on Harmonization of requirements for influenza vaccine欧盟-流感疫苗标准指南.pdf
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1、The European Agency for the Evaluation of Medicinal ProductsHuman Medicines Evaluation Unit12 March 1997CPMP/BWP/214/96COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTSCOMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS(CPMP)(CPMP)NOTE FOR GUIDANCE ON HARMONISATION OF REQUIREMENTSNOTE FOR GUIDANCE ON HARMONISAT
2、ION OF REQUIREMENTSFOR INFLUENZA VACCINESFOR INFLUENZA VACCINESDISCUSSION IN THE BIOTECHNOLOGY WORKING PARTYDISCUSSION IN THE BIOTECHNOLOGY WORKING PARTY(BWP)(BWP)TRANSMISSION TO THE CPMPTRANSMISSION TO THE CPMPTRANSMISSION TO INTERESTED PARTIESTRANSMISSION TO INTERESTED PARTIESDEADLINE FOR COMMENTS
3、DEADLINE FOR COMMENTSRE-SUBMISSION TOTHE BWPRE-SUBMISSION TOTHE BWPRE-SUBMISSION TO THE CPMPRE-SUBMISSION TO THE CPMPAPPROVAL BY THE CPMPAPPROVAL BY THE CPMPDATE FOR COMING INTO OPERATIONDATE FOR COMING INTO OPERATIONMarch 1996July 1996July 1996January 1997March 1997March 1997March 1997April 19977 W
4、estferry Circus,Canary Wharf,London E14 4HB,UKSwitchboard:(+44-171)418 8400 Fax:(+44-171)418 8551E_Mail:mailemea.eudra.org http:/www.eudra.org/emea.htmlHARMONISATION OF REQUIREMENTS FOR INFLUENZA VACCINESHARMONISATION OF REQUIREMENTS FOR INFLUENZA VACCINES(CPMP/BWP/214/96)(CPMP/BWP/214/96)A.A.YEARLY
5、 CHOICE OF INFLUENZA VIRUS STRAINS FOR VACCINESYEARLY CHOICE OF INFLUENZA VIRUS STRAINS FOR VACCINESWHO has three international influenza centres(at the National Institute for Medical Researchin Mill Hill UK;and at the Centers for Disease Control in Atlanta,USA and at CSL Ltd,Parkville,Australia),wh
6、ich are assisted by national laboratories,designated by WHO.Thenational laboratories isolate viruses and then refer them to an international centre for detailedantigenic analysis.Reports are regularly sent to WHO in Geneva.Once a year,in mid-February,a meeting of WHO experts takes place in Geneva,le
7、ading to arecommendation on the influenza A and B virus variants which should be used for theproduction of vaccine for the coming season,but there remains very broad flexibility withinthis recommendation.The WHO recommendations are aimed worldwide and therefore need tobe adapted to the epidemiologic
8、al situation of the European Union(EU).The predominantinfluenza viruses are believed to be similar from one Member State of the EU to another,There is thus little scientific justification for different composition of vaccines throughout theEU.As from 1992,a meeting of EU experts will have to be conv
9、ened each year after the WHOmeeting,as soon as practicallypossible,in order to take an EU wide decision regardinginfluenza virus strains for vaccine production for the next season,taking into consideration theepidemiology of influenza in the EU.B.B.LABELLINGLABELLINGThere should be clear information
10、 about influenza virus strains and season of use,since EUvaccines often contain virus strains which are related to,but not identical to thoserecommended by the WHO.This may cause confusion if some vaccine labels show the WHOstrains and others show the actual vaccine strains.Information on immediate
11、package,outer packaging and package leaflet should comply withCouncil Directive 92/27/EEC and in addition the labelling and package leaflets should contain:Immediate packageOuter packaging-season of usee.g.1997/98 season-WHO/EU recommended strainse.g.A/Wuhan/359/95(H3N2)-like strain-season of use-WH
12、O/EU recommended strainsfollowed byactual strains e.g.A/Wuhan/359/95(H3N2)-likestrain(A/Nanchang/933/95 RESVIR-9)-Statement that the vaccine complies with WHOrecommendation(northern hemisphere)and EUdecision for x seasonCPMP/BWP/214/961/18Package leafletThe actual vaccine strains(ie those approved a
13、t the annual meeting of EU experts)will also benamed in the dossier submitted for annual licensing and in the production and test protocols.C.C.POTENCY OF INFLUENZA VACCINEPOTENCY OF INFLUENZA VACCINEFor influenza vaccines to be acceptable throughout the EU,they should comply withtheEuropean Pharmac
14、opoeia(EP)requirements and contain 15 g HA per strain and per dose.The lower 95%confidence limits of the potency assay should indicate a content of at least 12g HA per strain and per dose.D.D.1.1.CONTROL AUTHORITY BATCH RELEASE OF INFLUENZA VACCINECONTROL AUTHORITY BATCH RELEASE OF INFLUENZA VACCINE
15、INTRODUCTIONINTRODUCTION1.11.1Directive 89/342/EEC relating to immunological products(consisting of vaccines,toxins or serums and allergens)provides in article 4.3.that,where a Member State considers itnecessary in the interests of public health,it may require that samples from each batch besubmitte
16、d for examination by a State laboratory or a designated laboratory for the followingmedicinal products:live vaccines;immunological medicinal products used in the primary immunisation of infants or othergroups at risk;immunological medicinal products used in public health immunisation programmes;newi
17、mmunological medicinal productsorimmunological medicinal productsmanufactured using new or altered kinds of technology or new for a particularmanufacturer,during a transitional period normally specified in the marketingauthorisation.Harmonisation of such examination by EU national authorities must b
18、e achieved to permiteffective batch release of vaccines within the EU.The objective of this batch examination is the verification that the product is in conformitywith the approved specifications.The testing has to be completed within 60 days of receiptof the samples.1.21.2Where a Member State has e
19、xamined a batch of a product and declared it to beinconformity with the approved specifications,anotherMember State may not repeat thisexamination for the purpose of release.The objective of this document is the harmonisation of control tests carried out in theframework of batch examination in order
20、 to achieve mutual recognition.1.31.3Batch release should be carried out by a control authority with recognised competencein batch release of influenza vaccines.A vaccine batch released by one Member State must beacceptable to other Member States.Batch release depends upon mutual confidence andeffec
21、tive exchange of information between the Member States.The batch release proceduresCPMP/BWP/214/962/18outlined below are phased to deal with vaccine submissions under normal circumstances(phase 1)and abnormal circumstances(phase 2).Phase 1 of batch release is necessary for allvaccine batches whereas
22、 phase 2 of batch release is introduced under the special circumstancesdescribed below.Test methods and results for phases 1 and 2 must comply with theEuropean Pharmacopoeia monograph on influenza vaccines.1.41.4Manufacturers are responsible for presenting release certificates delivered by thecompet
23、ent authorities when required.Records of batch release tests(phases 1 and 2)and the full documentation submitted by themanufacturer should be kept for at least 10 years by the control authority.They should beavailable to other EU control authorities upon request.2.2.2.12.1PHASE 1 OF BATCH RELEASE:PH
24、ASE 1 OF BATCH RELEASE:PROTOCOLPROTOCOL SUBMISSIONSUBMISSION ANDAND BATCHBATCHRELEASE TESTS(BASIC EP TESTS)RELEASE TESTS(BASIC EP TESTS)Protocol submissionProtocol submissionThe manufacturers detailed protocol of production and testscarried out according to theEuropean Pharmacopoeia monograph on inf
25、luenza vaccines shall be approved by the controlauthority for each vaccine batch.The protocol should be based upon the WHO summaryprotocol for influenza vaccine(inactivated)(WHO Technical Report Series638,1979)anexample of which is illustrated in paragraph 5.Manufacturers should submit full details
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