The European& International Regulatory Environments.ppt

TheEuropean&InternationalRegulatoryEnvironmentsStéphaneCallewaertRegulatoryPolicy&Intelligence,GlobalRegulatoryAffairs,inesULBPHARMEDModule6:DrugSafetyEvaluation,Pharmacovigilance&RegulatoryAffairs-April24th,2013OutlineEURegulatoryEnvironmentEUpharmaceuticallegislation:basicprinciplesEUClinicalTrialsDirectiveEURegistrationProcedures:CP&MRP/DCPPost-AuthorisationVariationsEUPaediatricRegulation:impactondevelopmentandregistrationNewPharmacovigilancelegislativerequirementsUSRegulatoryEnvironmentFDA&relevantlegislationIND&BLAJapaneseRegulatoryEnvironmentLawandrelevantauthorities(MHLW,PMDA,NIID)ClinicalTrialsNotification&…1995200020032004200520062007EMEACentralisedProcedure MutualRecognitionProcedureOrphanDrugsRegulationAnnexI(toDirective2001/83/EC)(CTD)NewLegisl.RegulationLegisl.onAdvancedTherapyEnlargement(to15MS)Enlargementto25MS(CY,CZ,EE,HU,LT,LV,MT,PL,SI,SK)Enlargementto27MS(BG&RO)BirthoftheEMEA2008EnlargedScopeofCP2010NewVariationRegulationNewPharmacovigilancelegislationFuture…AccessionofCroatia2012Implem.ofNew(JulyPETENTAUTHORITIES(>3500EUROPEANEXPERTS)StructureoftheEuropeanMedicinesAgency(EMA)+NO/IS(EEACountries)-22Languages(WorkingLanguageEN)1scientificexpertmembernominatedbyeachMSand1alternate1scientificexpertmemberfromNOandISand1alternate(observers)5co-positionChairman(;SE)&Vice-Chairman(;UK)mitteeforHumanMedicinalProducts)missiononnewmedicinalproducts/variation/renewal/lineextensiononarbitration/referralproceduresAdvisingongeneralEUguidelines/policiesScientificAdvice&passionateUsetoMSsContributiontoICHprocessEstablishWorkingParties,SAGs&ExpertGroupsDeliveringopinionstoWHOCHMPmai