Nat ional Medicines Agencies roles in Pharmacovigilance
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Transcript of Nat ional Medicines Agencies roles in Pharmacovigilance
National Medicines Agencies roles in Pharmacovigilance EU legislation for VMPsIstanbul, 18 – 19 April 2011
Jiří BurešInstitute for State Control of Veterinary Biologicals and Medicines
Pharmacovigilance – legal basis Directive 2001/82/EC, as amended by Dir.
2004/28/EC Art. 72 - 79
Regulation (EC) 726/2004 Art. 46 - 54 Commission Regulation (EC) No 540/95,
arrangements for reporting suspected unexpected adverse reactions which are not serious, whether arising in the Community or in a third country, to centrally authorised medicinal products for human or veterinary use
Pharmacovigilance – guidelines (1) European Commission Guidelines
http://ec.europa.eu/health/documents/eudralex/vol-9/index_en.htm
EU Pharmacovigilance Rules for Human and Veterinary Medicinal Products (Version June 2004)
Guideline on monitoring of compliance with pharmacovigilance regulatory obligations and pharmacovigilance inspections for veterinary medicinal products (March 2007)
Pharmacovigilance – guidelines (2) EMA guidelines See
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000170.jsp&murl=menus/regulations/regulations.jsp&mid=WC0b01ac058002ddca for a full list of guidelines
Guidelines dedicated to competent autrhorities: Guideline on procedures for competent authorities for
pharmacovigilance information for veterinary medicinal products
Guideline on harmonising the approach to causality assessment for adverse reactions to veterinary medicinal products
Pharmacovigilance – guidelines (3) Guideline on a strategy for triggering
pharmacovigilance investigations preceding regulatory actions by EU competent authorities
PSUR Assessment Report template for use by Member States
Note for guidance pharmacovigilance of veterinary medicinal products
Recommendation for the basic surveillance of Eudravigilance Veterinary data
Pharmacovigilance – guidelines (4)Electronic reporting
Scope of veterinary pharmacovigilance (1) Clinical safety of veterinary medicinal products
Benefit : risk for target & non-target species Lack of expected efficacy and misuse Human reactions to veterinary medicines
User safety Epidemio-surveillance of resistance Potential environmental issues
Environmental Violation of MRLs
Consumer safety Transmission of any infectious agents via VMPs
3rd countries
Scope of veterinary pharmacovigilance (2) Safety following off-label use of veterinary
medicinal products Additional information collated by the
veterinary pharmacovigilance (serious) abuse of veterinary medicinal products medicated feeds investigation following reaction
after use of a medicated pre-mix use of human MPs in animals
Pharmacovigilance as a discipline (1) Scientific
Data collection and analysis, signal detection Continuous Benefit : risk of VMPs Causality evaluation / Assessment of reports (PSURs)
Regulatory Requirements for MAHs Requirements for vets / health care professionals Requirements for NCAs Actions on VMPs due to pharmacovigilance Art. 78 referrals Pharmacovigilance inspections Description of the pharmacovigilance system in the dossier
submitted in support of the MA applications
Pharmacovigilance as a discipline (2) Organisational
Promotion of pharmacovigilance Education (vets, farmers, MAHs) National / EU level (e.g. PSUR worksharing) Pharmacovigilance x Marketing authorisation Pharmacovigilance x Inspections / RAS
Pharmacovigilance reporting - ? Room for simplification (1)
Pharmacovigilance reporting - ? Room for simplification (2)
Pharmacovigilance reporting - ? Room for simplification (3)
Pharmacovigilance in the current legislation
Directive 2004/28/EC introduced higher importance for veterinary
pharmacovigilance in the product lifecycle One renewal of MA for VMPs
Two if justified by pharmacovigilance Benefit : risk evaluation througout the product lifecycle PSURs
Role Frequency
…..Current development in the area of human medicines
National authorities roles
Creation of national legal framework for veterinary pharmacovigilance Priority area In compliance with EU legislation
Dir. 2001/82/EC, Reg. 726/2004 Detailed satutory requirements harmonised at the EU level for
MAHs Limited room for any national requirements Specific national requirments – likely to introduce increased
administrative burden and may impair efficiency of the system as such
Room / need for national arrangements with respect to vets / health care professionals / farmers (animal owners)
National authorities roles Establishment of national pharmacovigilance
systems Priority area Pharmacovigilance system – to capture as much
pharmacovigilance incidents occuring in the field as possible CZ – approx 1 ‰ of incidents reported through the official
pharmacovigilance channels Quality of reports Rely as much as possible on science, proffession, ethics Statutory requirements, however, necessary
National authorities roles
Establishment of national pharmacovigilance systems All important stakeholders need to be targeted
MAHs Vets Animal owners
Pro-active approach by the NCA Feed back to the reportes Science / professional approach Sharing of information Transparency Promotion, Education
National authorities roles
Electronic reporting (EV VET) Statutory requirements as from November 2005 in
the EU/EEA Exchange, processing and evaluation of
pharmacovigilance reports as required by the legislation EU bodies (EMA) Member States Industry
Data analysis EVVet DataWarehouse
National authorities roles
Electronic reporting (EV VET) Recommendation for the basic surveillance of
Eudravigilance Veterinary data (EMA/CVMP/PhVWP/471721/2006)
Mainly for centrally authorised products at the moments
Further development EU product database
EudraPharm project
National authorities roles
Links to MA departments / authorities Pharmacovigilance – integral part of the benefit :
risk evaluation of VMPs Training Communication channels between the MA assessors
and pharmacovigilance assessors Description of the pharmacovigilance system (Part
I) Pre-authorisation evaluation
In general, limited information available Post-authorisation evaluation
National authorities roles
Links to inspection departments / authorities Pharmacovigilance reports – quality defects
investigations (Product related) inspections in MAHs /
manufactures Pharmacovigilance inspections
Planning Methodology
National authorities roles Pharmacovigilance inspections
Detailed guidance adopted in 2007 Guideline on monitoring of compliance with
pharmacovigilance regulatory obligations and pharmacovigilance inspections for veterinary medicinal products (ENTR/ F2 D(2007))
Still large differences between the Member States Difference from other type of enforcement inspections
Collaborative approach Helping to understand role and importance of veterinary
pharmacovigilance in the lifecycle of VMPs Importance of the efficient and working systems at the MAHs
National authorities roles
Promotion of veterinary pharmacovigilance Essential part of the daily job for the
pharmacovigilance staff Has to reflect national conditions All stakeholders to be addressed Explanation of importance of effective
pharmacovigilance reporting for the benefit : riks profile of VMPs Safe and effective use of VMPs by vets / animal owners in
the field
National authorities roles Different forms may be employed
Feedback to reports Websites Dedicated websites
CZ – VETTOX Assistance in investigations of the pharmacovigilance reports
! Industry role to be considered as well Availability of local pharmacovigilance contacts points
Language, assistance, feedback Simple tools for pharmacovigilance reporting by vets / farmers Articles in the scientific (professional) journals Education (students, vets, farmers) Others
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