The New(ish) European
Pharmacovigilance Legislation
ISCT Satellite GRP Workshop
27 January 2013
Jacquelyn Awigena-Cook
Associate Director, Head PV Policy
Disclaimer
The presentation is intended for educational purposes only
and does not replace independent professional judgement.
Statements of fact and opinions expressed are those of the
participant individually and, unless expressly stated to the
contrary, are not the opinion or position of Janssen
Pharmaceutical Research and Development, Division of
Janssen Cilag Ltd or its affiliates.
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The New European Pharmacovigilance Legislation
“This new public health legislation is far reaching in
scope and depth and goes far beyond any narrow
concept of pharmacovigilance.”
-
European Medicines Agency, “Planning for the Implementation of the New Legislation on
Pharmacovigilance” (31 January 2011)
Objectives:
Promote and protect public health by reducing burden of ADRs and
optimising the use of medicines:
• Strengthen & rationalise the system
• Science based & risk-proportionate
• Integrate benefit and risk
• Ensure robust & rapid decision-making
• Increase transparency & provide better information
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The New European Pharmacovigilance Legislation
Amending Legislation
Regulation 1235/2010
*Directive 2010/84/EC
Published 31 Dec 2010
Implementing Regulation
Published 20 June 2012
Good PV Practice (GVP)
Guidance
Published 25 June 2012**
*Directive 2010/84/EC must be transposed into national law in order to
be effective
**Not all modules released yet
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Good Pharmacovigilance Practice (GVP)
• INTRODUCTION Legal Basis and Structure of
Pharmacovigilance Guidance
• MODULE I Pharmacovigilance Systems
and their Quality Systems
• MODULE II Pharmacovigilance System
Master File
• MODULE III Pharmacovigilance
Inspections
• MODULE IV Pharmacovigilance Audits
• MODULE V Risk Management Systems
• MODULE VI Management and Reporting of
Adverse Reactions to Medicinal Products
• MODULE VII Periodic Safety Update
Report
• MODULE VIII Post-Authorisation Safety
Studies
• MODULE IX Signal Management
• MODULE X Additional Monitoring
• MODULE XI Public Participation in
Pharmacovigilance
• MODULE XII Continuous Pharmacovigilance,
Ongoing Benefit-Risk Evaluation, Regulatory
Action and Planning of Public Communication
• MODULE XIII Incident Management
• MODULE XIV International Collaboration
• MODULE XV Safety Communication
• MODULE XVI Tools, Educational Materials and
Effectiveness Measurement for Risk
Minimisation
*Also, product and population specific
guidance
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The New European Pharmacovigilance Legislation
• Highlights of major changes
– PV System Master File (PSMF) replacing the Detailed
Description of Pharmacovigilance Systems (DDPS)
• PV system must meet quality standards
• Greater transparency of internal audit findings
• Metrics on pharmacovigilance performance in the Annexes
– Risk management plan for all new products
• Emphasis on proportionate risk minimisation procedures
– Legal basis to require Post Authorisation Safety Studies
and Post Authorisation Efficacy Studies
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The New European Pharmacovigilance Legislation
• Highlights of major changes
– Additional monitoring list
– ADR management and reporting
• Changes to the definition of an ADR
• Increased requirements for collection of data
• ADR reporting simplified
– Periodic Safety Update Report (PSURs)
• Risk proportionate
• Reorientation toward benefit-risk
• Greater cumulative context
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The New European Pharmacovigilance Legislation
• Highlights of major changes
– Legal basis for signal detection
• Fuller datasets for signal detection – all sources
• Signal management principles
• Signal tracking systems
– Linking safety documentation throughout the life cycle
IB
DSUR
EURMP
SmPC
PSUR
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The New European Pharmacovigilance Legislation
• Highlights of major changes
– Pharmacovigilance Risk assessment Committee (PRAC)
with central and national authorisations decision making
– Urgent Union procedures for serious issues
– Transparency and communication
• Publically available information on web portals
– Public participation
• Patient organisation members of PRAC
• Hearings on safety matters
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The New European Pharmacovigilance Legislation
• Early Challenges
– Increased demands requiring resources
– Potential differences and conflicts in pharmacovigilance
requirements across different Health Authorities
– A need to change to a new way of thinking about
pharmacovigilance with a patient centred approach and
greater transparency
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The New European Pharmacovigilance Legislation
• Some considerations
– The full implementation of the EU PV Legislation will
• Require major changes in PV systems
• Will not be realised for some years yet
– Learning and adjusting
• Implementation of changes in Directives by National
Competent Authorities is still unclear in some cases
• Definitions still being developed
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