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

Thank you for your Thank you for your attention !attention !

bures@uskvbl.cz