The New( ish ) European Pharmacovigilance Legislation

1. The New(ish) European Pharmacovigilance Legislation Jacquelyn Awigena-Cook Associate Director, Head PV Policy

2. Disclaimer

3. 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

4. The New European Pharmacovigilance Legislation *Directive 2010/84/EC must be transposed into national law in order to be effective **Not all modules released yet

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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

11. 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