european enforcement of pharmacovigilance and inspection trends is compliance possible within the...
TRANSCRIPT
European Enforcement European Enforcement of of
Pharmacovigilance and Inspection TrendsPharmacovigilance and Inspection Trends
Is compliance possible Is compliance possible within the EU?within the EU?
June 7, 2007June 7, 2007
Dr. M.C. KosterDr. M.C. KosterCEO Vigilex Group CEO Vigilex Group
EuropeEurope
27 EU member states (per 1 January 2007)27 EU member states (per 1 January 2007)
3 European EFTA countries have chosen to 3 European EFTA countries have chosen to
follow the EU legislation & guidance for PVfollow the EU legislation & guidance for PV
(Norway, Iceland and Liechtenstein)(Norway, Iceland and Liechtenstein)
Together, these 30 countries are referred to Together, these 30 countries are referred to
as the EEA (European Economic Area)as the EEA (European Economic Area)
Requirements for a MAHRequirements for a MAH
QPPV, residing within the EEA and permanently and QPPV, residing within the EEA and permanently and continuously at his disposalcontinuously at his disposalSingle QPPV for all products and responsible for:Single QPPV for all products and responsible for:– overview of safety profile all productsoverview of safety profile all products– establishment, maintenance/management of the PV systemestablishment, maintenance/management of the PV system– oversight in terms of structure and performance of e.g. oversight in terms of structure and performance of e.g.
staffing, procedures, database(s), training, QC processes and staffing, procedures, database(s), training, QC processes and QA activitiesQA activities
– timeliness and correctness of expedited and periodic reports timeliness and correctness of expedited and periodic reports submittedsubmitted
– ongoing risk-benefit evaluation of all productsongoing risk-benefit evaluation of all products– ensure any request from a competent authority is answered ensure any request from a competent authority is answered
fully and promptlyfully and promptly– must provide any information relevant to the evaluation of must provide any information relevant to the evaluation of
benefit and riskbenefit and risk– Etc., Etc.Etc., Etc.
Requirements for a CARequirements for a CAEC is the CA for pharmaceutical products EC is the CA for pharmaceutical products authorised centrally and authorised centrally and has the responsibility for the overall community system of PV; assisted by the CHMP and EMEA (European Medicines Agency)EMEA (European Medicines Agency)Individual MSs have Individual MSs have the responsibility for all other other products when there is a products when there is a marketing authorisation in their country (national procedures, including the mutual recognition and decentralised procedure) – continually monitors the safety profile of the products available
on its territory and takes appropriate action where necessary and monitors the compliance of MAHs;
– should ensure that MAHs implement, when appropriate, Risk Management Plans to effectively monitor and manage risks associated with the safety of their products;
– should ensure that PV data are shared between Member States and the Agency via EudraVigilance;
– shall ensure, by repeated inspections, compliance with required shall ensure, by repeated inspections, compliance with required activitiesactivities
“If the law supposes that,” said Mr. Bumble,… “the law is a ass—an idiot. If that’s the eye of the law, the law is a bachelor; and the worst I wish the law is that
his eye may be opened by experience.”CHARLES DICKENS, Oliver Twist, chapter 51, p. 489
Examples of obstaclesExamples of obstacles
15 c-day deadline for expedited reports, but 15 c-day deadline for expedited reports, but no sign off by CAs during the weekend or no sign off by CAs during the weekend or bank holidaysbank holidaysElectronic reporting mandatory since Electronic reporting mandatory since November 2005; many CAs not ready yetNovember 2005; many CAs not ready yetGood PV staff is rare and so is a QPPVGood PV staff is rare and so is a QPPVVolume 9A, containing a substantial number Volume 9A, containing a substantial number of changes, is in effect immediatelyof changes, is in effect immediatelyVolume 9A will be regularly updated (225 Volume 9A will be regularly updated (225 pages), but changes are not markedpages), but changes are not markedStill countries requiring reports in national Still countries requiring reports in national languagelanguage
Examples of duplicationExamples of duplication
Literature searchesLiterature searches– MAHs are expected to maintain awareness of individual MAHs are expected to maintain awareness of individual
case reports in publications through accessing weekly a case reports in publications through accessing weekly a
widely used systematic review and reference databasewidely used systematic review and reference database – For a company wit 100 products this involves at average For a company wit 100 products this involves at average
110-120 hours a week110-120 hours a week
PSUR review for nationally authorised PSUR review for nationally authorised products, in principle, by 30 EEA countriesproducts, in principle, by 30 EEA countriesExpedited reports could be sent all to the Expedited reports could be sent all to the EudraVigilance database in stead of in a EudraVigilance database in stead of in a complex structure to individual MSscomplex structure to individual MSs
Inspection trendsInspection trends
A. RoutineA. RoutineNational inspection programsNational inspection programs
For centrally authorised products the CHMP will For centrally authorised products the CHMP will determine a programdetermine a program
B. TargetedB. TargetedTriggered but without a specific concernTriggered but without a specific concern
Triggered but with a specific product or actual Triggered but with a specific product or actual non-compliancenon-compliance
Outcome of inspections are not predictable as Outcome of inspections are not predictable as findings vary per country and per inspectorfindings vary per country and per inspector
Recipe for benefit to public healthRecipe for benefit to public health
Reporting to EudraVigilance onlyReporting to EudraVigilance onlyUse resources better:Use resources better:– simplified PSURs for older productssimplified PSURs for older products– simplify reporting for older productssimplify reporting for older products– No global & local literature searches by all No global & local literature searches by all
companiescompanies
Exempt PV from the strict data privacy Exempt PV from the strict data privacy DirectiveDirectiveAbandon the macho behavior of individual Abandon the macho behavior of individual countriescountries
HarmoniseHarmonise, , HarmoniseHarmonise, Harmonise, , Harmonise, HarmoniseHarmonise
