1 / 25

Nat ional Medicines Agencies roles in Pharmacovigilance

Nat ional Medicines Agencies roles in Pharmacovigilance. EU legislation for VMPs Istanbul, 18 – 19 April 2011 Jiří Bureš Institute 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

darena
Download Presentation

Nat ional Medicines Agencies roles in Pharmacovigilance

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. National Medicines Agencies roles in Pharmacovigilance EU legislation for VMPs Istanbul, 18 – 19 April 2011 Jiří Bureš Institute for State Control of Veterinary Biologicals and Medicines

  2. 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

  3. 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)

  4. 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

  5. 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

  6. Pharmacovigilance – guidelines (4)Electronic reporting

  7. 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

  8. 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

  9. 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

  10. 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

  11. Pharmacovigilance reporting - ? Room for simplification (1)

  12. Pharmacovigilance reporting - ? Room for simplification (2)

  13. Pharmacovigilance reporting - ? Room for simplification (3)

  14. 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

  15. 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)

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. National authorities roles • Links to inspection departments / authorities • Pharmacovigilance reports – quality defects investigations • (Product related) inspections in MAHs / manufactures • Pharmacovigilance inspections • Planning • Methodology

  22. 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

  23. 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

  24. 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

  25. Thank you for your attention ! bures@uskvbl.cz

More Related