The information contained in these slides is for general purposes only and presents the state of knowledge at November 30, 2011

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2 The information contained in these slides is for general purposes only and presents the state of knowledge at November 30, 2011 No rights can be derived from this information The Medicines Evaluation Board accepts no liability for direct or consequential damage resulting from teh use of, reliance on or action taken on the basis of this information provided during this session 2

3 Better protecting the patients Be aware of the system and your role

4 Overzicht presentatie Introductie,doel van de veranderingen Wetgeving Verordening Richtlijn Implementatie maatregelen Belangrijke veranderingen in vogelvlucht Inleiding op de nieuwe wetgeving 4

5 Pharmacovigilantie Spontaneous reports 2001 cerivastatine 2004 Vioxx 1995 PSURs RMPs 2006 EU consultation

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8 Pharmacovigilantie Spontaneous reports 2001 cerivastatine 2004 Vioxx 1995 PSURs RMPs 2010 Regulation Directive 2006 EU consultation

9 European Commission schatting 5% of all hospital admissions due to ADRs 5% of all hospital patients experience an ADR ADRs5 th most common cause of hospital death 197,000 deaths per year in EU caused by ADRs Total societal cost 79 billion

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11 Aims of the new legislation Clear roles and responsibilities Integrate benefit and risks Science based ( embrace the hierarchy of evidence) Risk based /proportionate Increased planning/proactivity Ensure robust and rapid decision making Strengthening the EU network Engage patients and HCPs Increase transparancy and Reduce accountability duplication/redundancy Provide better information on medicines

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13 Overzicht presentatie Introductie,doel van de veranderingen Wetgeving Verordening Richtlijn Implementatie maatregelen Belangrijke veranderingen in vogelvlucht 13

14 Regulation/verordening 1235/2010 Focus op EU procedures en de taken van EMA Directive/richtlijn 2010/84/EC Focus op farmacovigilantie activiteiten in de lidstaten met het oog op nationale registraties Maatregelen gelden voor de centrale (CAPs) en niet centrale producten (non CAPS) Moeten samen gelezen worden, beiden treden in werking juli

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16 Implementing measures EC EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Health systems and products Pharmaceuticals Brussels, SANCO/D3/FS/cg/ddg1.d.3(2011) IMPLEMENTING MEASURES IN ORDER TO HARMONISE THE PERFORMANCE OF THE PHARMACOVIGILANCE ACTIVITIES PROVIDED FOR IN DIRECTIVE 2001/83/EC AND REGULATION (EC) NO 726/2004 THE CONCEPT PAPER SUBMITTED FOR PUBLIC CONSULTATION Deadline for Public Consultation: 7 November 2011 This document does not represent an official position of the European Commission. It is a tool to explore the views of interested parties on a preliminary draft. The suggestions contained in this document do not prejudge the form and content of any future proposal by the European Commission. 16

17 Implementing measures EC Pharmacovigilance system master file Quality systems for the performance of pharmacovigilance activities Common obligations Quality systems for the performance of pharmacovigilance activities by marketing authorisation holders Quality systems for the performance of pharmacovigilance activities by national competent authorities and EMA Signal detection and risk identification Use of terminology Transmission and Submission requirements 17

18 Implementing measures EC G. Transmission and Submission requirements Annex I Electronic submissions of suspected adverse reactions Annex II Risk management plans Annex III Electronic periodic safety update reports Annex IV Protocols, abstracts and final study reports for the post-authorisation safety studies 18

19 Overzicht presentatie Introductie,doel van de veranderingen Wetgeving Verordening Richtlijn Implementatie maatregelen Belangrijke veranderingen in vogelvlucht 19

20 Wat gaat de wet veranderen? Risk management plan Literatuur monitoring Additional monitoring Referrals union procedures PSURs Post authorisation safety studies renewal Bijwerkingen Meten effecten risk minimisation Wetenschappelijke committees /PRAC Webportals Farmacovigilantie master file Farmacovigilantie inspecties Transparantie 20 Signaal detectie Worksharing

21 Overzicht presentatie Introductie,doel van de veranderingen Wetgeving Verordening Richtlijn Implementatie maatregelen Belangrijke veranderingen in vogelvlucht PRAC PASS PhV MF Additional monitoring 21

22 Pharmacovigilance Risk Assessment Committee (PRAC) Mandate (R61a) All aspects of the risk management of the use of medicinal products including the detection, assessment, minimisation and communication relating to the risk of adverse reactions, having due regard to the therapeutic effect of the medicinal product, the design and evaluation of post-authorisation safety studies and pharmacovigilance audit 222 2

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26 Besluitvormings model PSUR PASS Union procedures (art. 31, 107i) RMP CMD(h) (no CAP) PRAC recommendation: regulatory action CHMP (at least 1 CAP) Position = maint., var., susp., revoc. Opinion = maint., var., susp., revoc. If consensus: agreement NO consensus: position majority COMMISSION MS: adopt measures MAH: submit variation Decision addressed to MS Decision modifying MA (CAP)

27 Overzicht presentatie Introductie,doel van de veranderingen Wetgeving Verordening Richtlijn Implementatie maatregelen Belangrijke veranderingen in vogelvlucht PRAC PASS PhVS-MF Additional monitoring 27

28 PASS Post-authorisation Safety Studies (PASS) (1/4) Strengthened legal basis Regulators can require PASS at first authorisation Regulators can require PASS post-authorisation PASS is a condition of the authorisation and is legally binding In the event that the same safety concern applies to more than one medicinal product, the EMA/national competent authority shall encourage the marketing authorisation holders concerned to conduct a joint post-authorisation safety study 28

29 PASS Post-authorisation Safety Studies (PASS) (2/4) Principles for and oversight of PASS Definition: Principles and oversight for non-interventional PASS which are: Any study relating to an authorised medicinal product conducted with the aim of identifying, characterising or quantifying a safety hazard, confirming the safety profile of the medicinal product, or of measuring the effectiveness of risk management measures initiated, managed or financed by the MAH voluntarily or pursuant to obligations imposed [by regulators] and which involve the collection of data on suspected adverse reactions from patients or healthcare professionals. Still may have additional MS requirements on well being and rights of participants in non-interventional PASS 29

30 PASS ALL PASS ALL PASS Initiated, managed or financed by MAH, involving data collection from patients or HCPs PASS Required by regulators PASS In more than one MS 30

31 PASS Post-authorisation Safety Studies (PASS) (3/4) Principles for and oversight of all PASS (initiated, managed or financed by MAH) The studies shall not be performed where the act of conducting the study promotes the use of a medicinal product. Payments to healthcare professionals for participating in noninterventional PASS shall be restricted to the compensation for time and expenses incurred. National competent authority may require the MAH to submit the protocol and the progress reports to the competent authorities of the MSs in which the study is conducted. MAH shall send the final report to the competent authorities of the MSs in which the study was conducted within 12 months of the end of data collection. Any new information which might influence the evaluation of the riskbenefit balance of the medicinal product shall be communicated [by company] to the competent authorities of the MS in which the product has been authorised. 31

32 PASS Post-authorisation Safety Studies (PASS) (4/4) Principles for and oversight of PASS for studies required by regulators Protocols actively approved prior to study (single country = MS, multiple country = PRAC) Protocol amendments actively approved Final report and abstract submitted Automatic, formal assessment and decision-making based on results Company updates product information 32

33 PASS ALL PASS ALL PASS Initiated, managed or financed by MAH, involving data collection from patients or HCPs PASS Required by regulators PASS In more than one MS 33

34 Overzicht presentatie Introductie,doel van de veranderingen Wetgeving Verordening Richtlijn Implementatie maatregelen Belangrijke veranderingen in vogelvlucht PRAC PASS PhVS MF Additional monitoring 34

35 DDPS- PhVS master file 35

36 DDPS- PhVS master file The marketing authorisation holder should have: a pharmacovigilance system ensure the monitoring and supervision of authorised medicinal products recorded in a pharmacovigilance system master file permanently available for inspection (request CA). Applications for marketing authorisations should therefore be accompanied by a brief description of the corresponding pharmacovigilance system, location where the pharmacovigilance system master file is kept QPPV 36

37 DDPS- PhVS master file Pharmacovigilance system master file A detailed description of the pharmacovigilance system used by the marketing authorisation holder with respect to one or more authorised medicinal products. The national competent authority may at any time ask the marketing authorisation holder to submit a copy of the pharmacovigilance system master file. The marketing authorisation holder shall submit the copy at the latest 7 days after receipt of the request. 37

38 DDPS- PhVS master file The new Directive and RSegulation do not contain details on the content and maintenance of the PhV-MF. Elements of its content and maintenance will be required by implementing measures under consultation and the Good Vigilance Practices guidance under development. Important changes: No content of the PhVS-MF is submitted as part of the MAA Review of the PhVS-MF is on request 38

39 DDPS- PhVS master file D 104 QPPV : should reside and carry out tasks in the EU Legal basis for MSs to request a national nominated person for pharmacovigilance is introduced National nominated persons should report to the QPPV 39

40 DDPS- PhVS master file Currently DDPS Variations, type I or II Changes to PSMF content will not require variations Variations are only required (Directive article 8 ) change in QPPV PhVS-MF location The current proposal for the implementing measures: Specify changes to PhVSMF location notified via product list (Article 57 of the Regulation ) this address is the same as that of the QPPV. Since MAHs will simply be notifying NCAs/ EMA of an administrative change, only type IA variation are proposed. 40

41 Overzicht presentatie Introductie,doel van de veranderingen Wetgeving Verordening Richtlijn Implementatie maatregelen Belangrijke veranderingen in vogelvlucht PRAC PASS PhVS MF Additional monitoring 41

42 Additional monitoring Regulation art 23/Directive art 11 The Agency shall, in collaboration with the Member States, set up, maintain and make public a list of medicinal products that are subject to additional monitoring. That list shall include the names and active substances of: Medicinal products authorised in the Union that contain a new active substance which, on 1 January 2011, was not contained in any medicinal product authorised in the Union; any biological medicinal produc t not covered by point (a) authorised after 1 January At the request of the Commission, following consultation with the PRAC (Regulation, CAPs) At the request of the National Competent Authority following consultation with the PRAC (Directive, non CAPs) 42

43 Additional monitoring The list shall include an electronic link to the product information the summary of the risk management plan. The Agency shall remove a product from the list: 5 years after the Union Reference date (art 107) Unless 43

44 Additional monitoring R23/D59 SPC and PL shall include the statement This medicinal product is subject to additional monitoring. Statement preceded by a black symbol (selected by the Commission following a recommendation of the PRAC) followed by an appropriate standardised explanatory sentence For all medicinal products, a standardised text shall be included, expressly asking patients to communicate any suspected adverse reaction to his/her doctor, pharmacist, healthcare professional or directly to the national spontaneous reporting system referred to in Article 107a(1), specifying the different ways of reporting available (electronic reporting, postal address and/or others) in compliance with the second subparagraph of Article 107a(1) 44

45 EU the United States of Europe EU legislation: 27 different sets of national legislation 45

46 Volume 9A wordt : GVP Modulair van opzet Ontwikkeld door EMA samen met lidstaten Uit voor pubieke consultatie ( 8 weken) Planning: gefaseerd eerste wave januari 2012

47 GUIDANCE ON GOOD PHARMACOVIGILANCE PRACTICES 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 Audits MODULE V Risk Management Systems MODULE VI Data Management of Individual Case Safety Reports MODULE VII Periodic Safety Update Reports MODULE VIII Post-Authorisation Safety Studies MODULE IX Post-Authorisation Efficacy Studies (to be decided later) MODULE X Detection and Management of Signals and Information MODULE XI Additional Monitoring MODULE XII Public Participation in Pharmacovigilance MODULE XIII Continuous Pharmacovigilance, Ongoing Benefit-Risk Evaluation, Regulatory Action and Planning of Public Communication MODULE XIV Incident Management MODULE XV Referral Procedures for Safety Reasons MODULE XVI Safety Communications MODULE XVII Tools, Educational Materials and Effectiveness Measurement for Risk Minimisation 47

48 Thank you! Questions? Better protecting the patients Be aware of the system and your role

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Detailed guidance AEs reporting in clinical trials ( CT-3 ) Stefano Bonato, M.D. Pharmacovigilance Country Head Bayer HealthCare Pharmaceuticals

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