Building on Drug Safety - the new EU guidelines May 2012


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Claire Tilstone - MHRA

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Building on Drug Safety - the new EU guidelines May 2012

  1. 1. Safeguarding public healthBuilding on drug safety:How new EU regulations arechanging pharmacovigilanceClaire TilstoneMay 2012 ©
  2. 2. London 2012European Medicines Agency (EMA) and MHRA usheringin a new era in drug safety• Building on principles in volume 9A• Regulation (EU) No1235/2010• Directive 2010/84/EU (to be transposed into UK Human Medicines Regulation 2012)• Underpinned by a series of Implementing Measures and Transitional ArrangementsKey principles:9. Proportionality; risk-based approach10. Risks considered in the context of benefits11. Considering outcomes and effectiveness of regulation Slide 2 ©
  3. 3. Good pharmacovigilance practiceNew guidelines for conduct of pharmacovigilance in EUare outlines in Good Pharmacovigilance Practice (GVP)modulesWave I topics recently subject to public consultation:• I. Pharmacovigilance systems and their quality systems• II. Pharmacovigilance system master file• V. Risk management systems• VI. Management and reporting of adverse reactions• VII. Periodic Safety Update Report• VIII. Post-authorisation safety studies• IX. Signal managementFurther waves due to be published in 2012 coveringtopics such as communications and audit Slide 3 ©
  4. 4. Key areas• Audit and inspection• Adverse drug reaction (ADR) reporting and signalmanagement• Risk minimisation• Committees and referrals• Communications and transparency Slide 4 ©
  5. 5. Audit and inspectionRequirements for information provided to Member Statesand EMA about pharmacovigilance system(s) of marketingauthorisation holders (MAHs) change in several ways:• Summary information only on EU qualified person for pharmacovigilance(QPPV) and location of a pharmacovigilance system master file (PSMF)will be contained in marketing authorisations• Full descriptive information about pharmacovigilance systems will haveto be contained in PSMF, available to Competent Authorities on request)• Detailed requirements for PSMF concern its availability, structure,content and maintenance• PSMF will encompass pharmacovigilance system and may relate to oneor more products; content changes not automatically notifiable toCompetent Authorities• Differs from current Detailed Description of the Pharmacovigilancesystem (DDPS), which will be phased out from July 2012–15 Slide 5 ©
  6. 6. ADR reporting and signal management• Patients included as valid reporters of ADRs• Definition of ADR extended to include harm from “noxiousand unintended” reaction: ie, error, misuse, abuse, off-label• Centralised reporting to Eudravigilance (likely 2015)• EU-wide list of products subject to additional monitoring (toinclude biosimilars and biologicals); phasing out of UK BlackTriangle Scheme• PSURs: cumulative benefit-risk evaluation of signals• Rationalisation via: modular structure; waivers; risk-based Slide 6 ©
  7. 7. Risk minimisation• Focus: forward-planning; dynamic; proportionate;transparent; auditable• Risk management plans required for all new marketingauthorisations (MAs) from July 2012 (modular structure)• Post-authorisation safety/efficacy studies may be a newobligation (condition) on or after granting an MA Slide 7 ©
  8. 8. Committees and referrals• There will be a new EU committee: the PharmacovigilanceRisk Assessment Committee (PRAC) to advise current CHMPand CMDh committees• New oversight in relation to risk minimisation via assessmentof PSURs, RMP, PASS• Role also in referrals; transitional arrangements will outlinehow legislation affects trigger date Slide 8 ©
  9. 9. Communications and transparency• Role of MAHs: timely and objective notifications• National web portals to host range of transparencydocuments: - SPCs and PILs - Summaries of Risk Management Plans - Public Assessment Reports (including conditions) - Products under additional monitoring - ADR reporting forms• EMA web portal expected to host further information relatingto: - PASS abstracts, protocols and study reports - Committee details• There will be EU public hearings on drug safety Slide 9 ©
  10. 10. Further information and links• MHRA:• EMA:- Regulation: Directive: Draft Implementing Measures: Transitional arrangements: GVP modules: Union Reference Date list on PSUR periodicity consultation:]&jsenabled=trueEmail: Slide 10 ©