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New EU PV regulations
New EU PV regulations
New EU PV regulations
New EU PV regulations
New EU PV regulations
New EU PV regulations
New EU PV regulations
New EU PV regulations
New EU PV regulations
New EU PV regulations
New EU PV regulations
New EU PV regulations
New EU PV regulations
New EU PV regulations
New EU PV regulations
New EU PV regulations
New EU PV regulations
New EU PV regulations
New EU PV regulations
New EU PV regulations
New EU PV regulations
New EU PV regulations
New EU PV regulations
New EU PV regulations
New EU PV regulations
New EU PV regulations
New EU PV regulations
New EU PV regulations
New EU PV regulations
New EU PV regulations
New EU PV regulations
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New EU PV regulations

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  • 1. Dr. Vijay bhushanam
  • 2. New legislation - Goals           Reduce the burden of ADRs and optimise the use of medicines Clarify roles and responsibilities Science based, Risk based/proportionate approach Increase proactiveness, Reduce redundancy Integrate benefit and risk Ensure robust and rapid EU decision-making Strengthen the EU Network Engage patients and healthcare professionals Increase transparency, awareness and accountability Provide better information on medicines
  • 3. New legislation - Aims  Improve the EU-PV system  Simplify regulatory decision making  Provide a legal basis for proactive Pharmacovigilance  Involve patients more closely in the reporting of ADRs  Overall Objective: “To protect public health”
  • 4. New legislation - Timeline  2003: EC decision to undertake an assessment of PV system  2005: Independent study completed  2006- 2008: Research, consultation, policy development  2010: New legislation adopted by the European Parliament and European Council (Dec 2010)  2012: First wave of requirements entered into force (2nd July)  2012: GVP Guidelines (16 modules) finalized after public consultation (February and December 2012)
  • 5. Major/Key changes 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. The new Good Vigilance Practice Guidelines (GVP) The Pharmacovigilance Risk Assessment Committee (PRAC) The Pharmacovigilance System Master File (PSMF) Using a Periodic Benefit Risk Evaluation Report (PBRER) More stringent ICSR submission rules Publishing summaries of Risk Management Plans (RMP) Requirement to perform Post-Approval Safety Studies (PASS) Assignment of an Additional Monitoring Status Commitment to openness and transparency Eudravigilance policy to disclose postmarketing safety information to the Public
  • 6. Major/Key changes – GVP  Good Pharmacovigilance Guidelines(GVP):  Replaces Eudralex Volume 9A.  Applies to all medicinal products, irrespective of the MA granting procedure.  Divided into 16 modules.  Uses MedDRA terminology.
  • 7. Major/Key changes – GVP GVP - Table of Contents Status Introduction Completed Final GVP chapters • Modules Most of them Adopted •Product or populationb specific considerations Open for public consultation Final GVP Annex I - Definitions Adopted Final GVP annex II - Templates Adopted Final GVP annex III - Other pharmacovigilance guidance Most of them Adopted Final GVP annex IV - ICH guidelines for pharmacovigilance Adopted Final GVP annex V - Abbreviations Published Draft GVP chapters and annexes for public consultation Open for public consultation Templates for submission of comments Published Privacy statement for public consultation Published
  • 8. Major/Key changes – GVP Mod. no. Title Status Effective from I Pharmacovigilance systems and their quality systems Adopted 2nd July 2012 II Pharmacovigilance system master file Adopted 12th April 2013 III Pharmacovigilance inspections Adopted 12th Dec 2012 IV Pharmacovigilance audits Adopted 12th Dec 2012 V Risk management systems Adopted 2nd July 2012 VI Management and reporting of adverse reactions Adopted 2nd July 2012 VII Periodic safety update report Adopted 2nd July 2012 VIII Post-authorisation safety studies Adopted 25th April 2013 Adopted 25th April 2013 Member States' requirements for transmission of VIII add-I information on non-interventional PASS
  • 9. Major/Key changes – GVP Title Mod. no. Status Effective from IX Signal management Adopted 2nd July 2012 X Additional monitoring Adopted 25th April 2013 XI Public participation in pharmacovigilance Under Dev. Q3, 2013 XII Continuous PV, ongoing benefit-risk evaluation, regulatory action, planning of public communication Under Dev. Q3, 2013 XIII Incident management (to be included in module XII) Under Dev. Q3, 2013 XIV International cooperation Under Dev. Q3, 2013 XV Safety communication Adopted XVI Risk-minimisation measures: selection of tools and effectiveness indicators Under Dev. Q2, 2013 23rd Jan 2013
  • 10. Major/Key changes - PRAC  Pharmacovigilance Risk Assessment Advisory Committee (PRAC):  A new EMA committee  Meets monthly from September 2012  Replaces the Pharmacovigilance Working Party  Advises to  CHMP and CMDh  Members include (appointed by MS and EC)  Experts from the EU Member States  Representatives from Patient organisations  Representatives from Healthcare professionals
  • 11. Major/Key changes - PRAC  Due regard to  Risk Management Systems  Therapeutic effect of the products  Periodic Safety Update Reports  Signal detection  Additional Monitoring Status  Urgent procedures  Design and evaluation of PASS  Pharmacovigilance inspections
  • 12. Major/Key changes - PRAC
  • 13. Major/Key changes - PSMF  Pharmacovigilance System Master File (PSMF) replaces DDPS.  MA applicants and MAHs are required to maintain PSMF.  To be provided within 7 days upon request by the EMA.  The Pharmacovigilance System Summary comprises of:  a signed statement  the location of PSMF  the name and contact details of the QPPV  the Member States in which the QPPV resides and operates  proof that the applicant has a QPPV
  • 14. Major/Key changes - PBRER  Periodic Benefit Risk Evaluation Report (PBRER)  Replaces Periodic Safety Update Report (PSUR)  Scope changed from interval safety analysis to benefit-risk evaluation  Includes a Benefit versus Risk statement  New evaluation sections, including a section to give an overview on signals (tabulated as new, ongoing or closed)  Interval listings no longer required  Deletion of the chapter “Analysis of individual case histories”
  • 15. Major/Key changes - PBRER  Not required for generic products, well-established use products,      homoeopathic products and traditional herbal products Six-monthly reports, summary bridging reports, or addendum reports will not be accepted. Time interval between data-lock point and submission – expanded. New assessment procedure involving PRAC. Assessment will lead to automatic regulatory action (i.e, variation, suspension or revocation). Assessment reports of PSURs will be published on a European medicines web portal.
  • 16. Major/Key changes - ICSR  Individual Case Safety Report (ICSR) Submission Rules  Requirement to submit non-serious ICSRs is extended to cases reported from Post-authorization solicited settings such as:  Post-Authorisation Safety Studies (PASS)  Post-Authorisation Efficacy Studies (PAES)  Non-Interventional Studies (NIS)  Patient Support Program (PSP)  Market Research Studies (MRS)  Non-serious ICSRs shall be submitted within 90 days to EudraVigilance
  • 17. Major/Key changes - RMP  Risk Management Plan (RMP) is divided into several parts.  The RMP will include  a summary of the efficacy of the product.  an evaluation of the effectiveness of risk minimisation measures.  PRAC will have regulatory oversight of RMPs.  PRAC will appoint a rapporteur for an individual RMP, who will work with the (co-) rapporteur appointed by CHMP.  Summaries of RMPs shall be made publicly available via web portals.
  • 18. Major/Key changes - RMP  Educational materials for health professionals and patients are required in RMP for a new product.  UK version must be submitted to the MHRA prior to issue.  MA application (after 21 July 2012) are required to submit a RMP.  Includes generic MA applications also.  Should be submitted in template for the EU-RMP.  For MAs granted before 21 July 2012 without an existing RMP - no obligation to submit a RMP (unless concerns arise).
  • 19. Major/Key changes – PASS/PAES  Performing a PASS/PAES may be required at first     authorisation as well as post-authorisation. The Competent Authority may impose an obligation on the MAH to conduct such a study. If the same safety concern applies to more than one product a joined PASS may be advised. New information detected during such studies shall be communicated to the competent authority. Proposed format and content of study protocols/reports. (outlined in GVP module VIII)
  • 20. Major/Key changes – Additional monitoring list  The Additional Monitoring Status Can be assigned at any time of the product life cycle  Subjected to more intense scrutiny (same as UK’s ‘Black Triangle’ list).  Published on  MHRA site www.mhra.gov.uk/blacktriangle.  Also available on the EMA website.  EU-wide list (published by EMA) will replace the Black Triangle list previously published by the MHRA.  MAHs can remove Black Triangle status without contacting the MHRA. (for products that are not listed on additional monitoring list)
  • 21. Major/Key changes – Openness and transparency  Provides the public with information about  The safety of marketed medicines.  How to report suspected ADRs.  If MAHs want to make a public announcement, they shall inform the NCA, the EMA and the EC.  Two important changes  EU public hearings.  Creation of medicines web portals.
  • 22. Major/Key changes – Openness and transparency  The UK web portal is required to host  SPCs and PILs  UKPARs (now a legal requirement)  Summaries of RMPs for medicines authorised  Products subject to additional monitoring  The MA conditions with deadlines for fulfilment  Setup of interconnected web-portals:  European medicines web-portal (www.ema.europa.eu) maintained by the EMA  Will be linked to national web-portals  Alternative reporting media remains available
  • 23. Major/Key changes – EudraVigilance Access Policy  ICSRs are expected to be submitted by MAHs directly to EudraVigilance rather than via National Health Authorities  Formerly, only Member State HA, the EMA and the European Commission had access to EudraVigilance.  The EudraVigilance access policy is changed to allow HCPs, patients and consumers, as well as MAH and research organisations accessing the information
  • 24. Major/Key changes – ADR reporting/Signal management  New Definition of Adverse Reaction*:  A response to a medicinal product which is noxious and unintended.  Also covers  Medicinal errors  Uses outside the terms of the MA  off-label use  misuse  abuse *Article 1, 11-D
  • 25. Major/Key changes – ADR reporting/Signal management  Centralised reporting  By industry to the Eudravigilance database at EMA.  Will come into effect 6 months after the Eudravigilance functionality is approved.  Likely to be sometime in 2015.  Until then transitional measures will apply.  Inclusion of reports from patients as valid, reportable ADRs.  Only medication errors that result in a serious ADR should be submitted.  Non-serious cases should not be reported to EudraVigilance during the transitional period.  Sending non-UK serious consumer reports by the company is not mandatory.
  • 26. Major/Key changes – ADR reporting/Signal management OLD NEW
  • 27. Major/Key changes – ADR reporting/Signal management  MAHs should report cases from the literature.  Avoid duplication by monitoring the MHRA website.  MAHs should review sites under their control for valid cases.  No need to review internet sites not under the MAH’s control (blogs, chatrooms and social media pages).  MAHs will also be required to monitor the Eudravigilance database according to their level of access.  Signals should follow a process of validation, prioritisation and assessment.
  • 28. Major/Key changes – Audit/Inspection  PSMF should be made available to the NCA upon request.  Changes to PSMF will not be automatically notifiable to the Competent Authorities.  Transitional period for introduction of PSMF ends in July 2015.  Quality Systems:  MAHs, NCAs and the EMA will be required to have a quality system in place.  Particularly for resource management, staff training, procedural documentation, quality control, monitoring, and improvement.
  • 29. Major/Key changes – Audit/Inspection  Inspections:  Harmonisation of inspection activities in the EU.  Legal basis for the conduct of pre-authorisation inspections.  Adequate pharmacovigilance system as a condition of MA.  MA applicants should be aware that the PSMF may be requested.  For centrally authorised products, the Supervisory Authority will be determined by the PSMF location.  MHRA will continue to operate a risk-based inspection programme.
  • 30. Conclusion  New legislation:  Provides strong legal basis for use of MedDRA through all steps of the pharmacovigilance process  Major change project that will take a few years to fully implement  Provides an opportunity to greatly improve the European system for the benefit of public health
  • 31. THANK YOU

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