EMA Annual report 2010.pdf

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1、28June2011EMA/306870/2011OfficeoftheExecutiveDirectorAnnualreport2010AdoptedbytheManagementBoardinJune20117WestferryCircus●CanaryWharf●LondonE144HB●UnitedKingdomTelephone+44(0)2074188400Facsimile+44(0)2074188416E-mailinfo@ema.europa.euWebsitewww.ema.europa.euAnagencyoftheEuropeanUnion©E

2、uropeanMedicinesAgency,2011.Reproductionisauthorisedprovidedthesourceisacknowledged.Annualreport2010NoteonannexesPleasenotethattheannexesofthisreportarepublishedseparatelyonthewebsiteoftheEuropeanMedicinesAgencyhere.Annualreport2010EMA/306870/2011Page2/83MissionstatementThemissionoftheE

3、uropeanMedicinesAgencyistofosterscientificexcellenceintheevaluationandsupervisionofmedicines,forthebenefitofpublicandanimalhealth.LegalroleTheEuropeanMedicinesAgencyistheEuropeanUnionbodyresponsibleforcoordinatingtheexistingscientificresourcesputatitsdisposalbyMemberStatesfortheevaluati

4、on,supervisionandpharmacovigilanceofmedicinalproducts.TheAgencyprovidestheMemberStatesandtheinstitutionsoftheEUthebest-possiblescientificadviceonanyquestionrelatingtotheevaluationofthequality,safetyandefficacyofmedicinalproductsforhumanorveterinaryusereferredtoitinaccordancewiththeprovi

5、sionsofEUlegislationrelatingtomedicinalproducts.PrincipalactivitiesWorkingwiththeMemberStatesandtheEuropeanCommissionaspartnersinaEuropeanmedicinesnetwork,theEuropeanMedicinesAgency:providesindependent,science-basedrecommendationsonthequality,safetyandefficacyofmedicines,andonmoregener

6、alissuesrelevanttopublicandanimalhealththatinvolvemedicines;appliesefficientandtransparentevaluationprocedurestohelpbringnewmedicinestothemarketbymeansofasingle,EU-widemarketingauthorisationgrantedbytheEuropeanCommission;implementsmeasuresforcontinuouslysupervisingthequality,safetyand

7、efficacyofauthorisedmedicinestoensurethattheirbenefitsoutweightheirrisks;providesscientificadviceandincentivestostimulatethedevelopmentandimprovetheavailabilityofinnovativenewmedicines;recommendssafelimitsforresiduesofveterinarymedicinesusedinfood-producinganimals,fortheestab