欧盟中药注册 SOP

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1、StandardoperatingprocedureTitle:EstablishmentofCommunityherbalmonographsandCommunitylistentriesandrelateddocumentsStatus:PUBLICDocumentno.:SOP/H/3163LeadauthorApproverEffectivedate:24-NOV-10Name:EstelleCoquilletteName:AnthonyHumphreysReviewdate:24-NO

2、V-13Signature:ONFILESignature:ONFILESupersedes:SOP/H/3163(07-MAY-09)Date:17-NOV-10Date:17-NOV-10TrackWiserecordno.:26161.PurposeThepurposeofthisSOPistooutlinetheprocessesrelatedtotheestablishmentandpublicationofCommunityherbalmonographs(monographs)an

3、dentriestothe‘Communitylistofherbalsubstances,preparationsandcombinationsthereofforuseintraditionalherbalmedicinalproducts’(listentries),basedonHMPCassessments.TheSOPdoesnotdescribethestepsfortheidentificationofpriorityherbalsubstances/preparationsto

4、becoveredbyamonographand/orlistentry,northecompilationofthescientificdata/literaturepriortothestartoftheassessmentnorthecompilationofthecontentofthemonographsand/orlistentries.ThesestepsarecoveredbyotherSOPsandprocedures.2.ScopeThisSOPappliestoEurope

5、anMedicinesAgencystaffworkingintheHMPCsecretariatandinvolvedintheprocessesrelatedtotheestablishmentofmonographsand/orlistentriesandrelateddocuments.3.ResponsibilitiesItistheresponsibilityoftheHeadofRegulatory,ProceduralandCommitteeSupport(P-R)Sectort

6、oensurethatthisprocedureisadheredtowithintheHMPCsecretariat.Theresponsibilityfortheexecutionofaparticularpartofthisprocedureisidentifiedintheright-handcolumnofsection9.Procedure.4.ChangessincelastrevisionUpdatedtoreflecttheneworganisationalnamesinthe

7、Agencyandmajorchangesintheprocess:7WestferryCircus●CanaryWharf●LondonE144HB●UnitedKingdomTelephone+44(0)2074188400Facsimile+44(0)2074188416E-mailinfo@ema.europa.euWebsitewww.ema.europa.euAnagencyoftheEuropeanUnion©EuropeanMedicinesAgency,2010.Reprodu

8、ctionisauthorisedprovidedthesourceisacknowledged.systematicpublicationofacallforsubmissionofscientificdataatRapporteur’sappointmenttimepossibleearlypeer-reviewpossibleconsultationofQDGonthepharmaceuticalsectionsofamonograph/qualityissuessystemati