0. The New(ish) European Pharmacovigilance Legislation
ISCT Satellite GRP Workshop
27 January 2013
Jacquelyn Awigena-Cook
Associate Director, Head PV Policy

1. 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.

2. 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
The biggest change to pharmaceutical regulation in the EU since 1995
Encompasses a new ‘thinking’ about drug safety by European Commission and Parliament
The major changes alter the global PV systems for all pharmaceutical companies
Important to reflect on when interpretation is unclear – what is consistent and aligned with principles
The impact is far outside just the EEA

3. 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**
Amending legislation:
Completely replaced PV chapters in Regulation 726/2004 and Directive 2001/83/EC (expanded!)
Several new/revised articles throughout
Volume 9A Guidelines (Rules Governing Medicinal Products in the European Union: Pharmacovigilance for Medicinal Products for Human Use) will be replaced by the new Good Pharmacovigilance Practices (GVP) Modules
Full implementation will be January 2013, with changes to EudraVigilance to follow
Some of the GVP Modules are finalised, some in draft, some not yet released
*Directive 2010/84/EC must be transposed into national law in order to be effective
**Not all modules released yet

4. 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

5. 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

6. 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

7. 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
EU-RMP
SmPC
PSUR

8. 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

9. 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

10. 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