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Safety Reports: PBRER / PSUR

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The aim of Safety reports is describe the safety during the lifecycle of the medicinal product. These reports are necessary during development as well as during the authorization process or renewal. In addition, several of these reports may be required by Health Authorities in case of safety concerns.
This presentation contains a full overview about periodic safety update reports and all the information related with it.

Published in: Science
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Safety Reports: PBRER / PSUR

  1. 1. Safety Reports: PSUR/PBRER
  2. 2. Index 1. What is a Periodic Safety Update Report (PSUR)? 2. Objective of the PSUR 3. Periodicity, EU Reference Dates and Data lock Points 4. Exemption from submitting PSURS 5. EU single assessment of PSUR (PSUSA) 6. Summary of GVP Module VII 7. How to review a PSUR/PBRER Safety Reports: PSUR/PBRER
  3. 3. 1. WHAT IS A PERIODIC SAFETY REPORT (PSUR)? Periodic safety update reports (PSURs) are pharmacovigilance documents intended to provide an evaluation of the risk-benefit balance of a medicinal product for submission by marketing authorisation holders at defined time points during the post-authorisation phase. PBRER (Periodic Benefit Risk Evaluation Report) are referred to as PSUR since implementation in Europe via GVP module VII.
  4. 4. 2. OBJECTIVE OF THE PSUR (1) To present a comprehensive and critical analysis of new or emerging information on the risks and, where pertinent, new evidence of benefit to enable an appraisal of overall benefit risk. To contain an evaluation of new relevant information that became available to the MAH during the reporting interval, in the context of cumulative information: • Examine whether new information is in accord with previous knowledge of the benefit risk profile • Summarises relevant new safety information that may impact the benefit risk profile • Summarises any important new efficacy and effectiveness information • Conduct an integrated Benefit/Risk evaluation (where new important safety information has emerged)
  5. 5. 2. OBJECTIVE OF THE PSUR (2) This evaluation of risk-benefit assessment should be undertaken in the context of ongoing pharmacovigilance and risk management: Module VII: Post-authorization safety studies Module V: Risk management systems
  6. 6. 3. PERIODICITY (1) PSUR must be prepared at the following intervals: • Immediately upon request • Every six months from authorisation until product placed on the market • Every six months for first two years on the market • Annually for the next two years • Thereafter every 3 years Exception – frequency and dates of submission are laid down as a condition of the MA or determined otherwise in the list of Union Reference Dates (EURD List). Submit: • By day 70 for intervals up to 12 months • By day 90 for intervals in excess of 12 months
  7. 7. 3. INTERNATIONAL BIRTH DATE AND DATA LOCK POINT (2) The date of the first marketing approval for the medicinal product in any country in the world is the International Birth Date (IBD). Data lock point is the date designated as the cut-off for data to be included, based on IBD.
  8. 8. The EU Reference Dates List is a comprehensive list of active substances and combinations of active substances for which PSURs shall be submitted: • Legally binding • Periodicity defined on a risk-based approach The EU Reference Dates List was put in place in order to facilitate the harmonisation of Data Lock Points (DLPs) and frequency of submission of PSURs for medicinal products containing the same active substance or the same combination of active substances subject to different marketing authorisations, authorised in more than one Member State. EMA has published the list of Union reference dates and frequency of submission information which will be legally binding when Module VII becomes effective 2 July 2012. 3. EU REFERENCE DATES LIST (3)
  9. 9. EU reference dates list 3. EU REFERENCE DATES LIST (4)
  10. 10. The EURD list is a living document which will be amended whenever considered necessary by the PRAC, the CHMP or CMDh in response to the emergence of relevant new safety information, newly authorised substances and requests received from MAHs. Substances can be added or removed as appropriate. The EURD list is updated on a monthly basis; MAHs should therefore maintain an awareness of the current status of the list. PSURs shall also be submitted at any time immediately upon request by the regulatory authorities. 3. EU REFERENCE DATES LIST (EURD List) (5)
  11. 11. 3. EU REFERENCE DATES LIST (EURD List) REGULATORY NETWORK (6) 11 The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human, examine any question relating to marketing authorisation of a medicinal product in two or more Member States in accordance with the mutual recognition procedure or the decentralised procedure. Executive body of the European Union responsible for proposing legislation, implementing decisions, upholding the Union's treaties and day-to-day running of the EU. Helps protect and promote health in Europe by evaluating medicines for both human and veterinary use. Heatlh Authorities of each Member State The Committee for Medicinal Products for Human Use is the committee at the EMA that is responsible for preparing opinions on questions concerning medicines for human use. CHMP The committee at the EMA that is responsible for assessing and monitoring safety issues for human medicines. EMA PRAC National Competent Authorities (NCA)
  12. 12. 4. EXEMPTION FROM SUBMITTING PSURS Generics, well-established use, and traditional herbal medicinal products are exempted from submitting PSURs except in the following circumstances:  The marketing authorisation provides for the submission of PSURs as a condition.  PSURs is (are) requested due to concerns relating to PV data or due to the lack of PSURs relating to an active substance after the MA has been granted (e.g. when the “reference” medicinal product is no longer marketed). For the products where PSURs are no longer required to be submitted routinely, it is expected that marketing authorisation holders will continue to: • Evaluate the safety of their products on a regular basis and Report any new safety information that impacts on the benefit- risk profile or the product information.
  13. 13. 5. EU SINGLE ASSESSMENT OF PSUR (PSUSA) (1) PSUSA is a PSUR single assessment of substances contained in centrally authorised product(s) AND nationally authorised products. This assessment lead to legally binding outcomes: maintenance, variation, suspension, revocation of the marketing authorisation. Objectives: harmonise and strengthen the safety and benefit-risk review of medicines across the EU; increase the shared use of resources between competent authorities; Assessment by the PRAC with CHMP involvement (for CAP and CAP/NAP) or CMDh (for NAP) in case of regulatory action.
  14. 14. 5. EU SINGLE ASSESSMENT OF PSUR (PSUSA) (2)
  15. 15. 5. EU SINGLE ASSESSMENT OF PSUR (PSUSA) (3) The EMA publishes a list of outcomes for NAPs on their website while outcomes for CAPs are published as part of each medicine’s European public assessment report (EPAR). Any changes to the product information as a result of the PSUR assessment are implemented without subsequent variation for CAPs and through the appropriate variation at national level for NAPs. http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/g eneral/general_content_000620.jsp&mid=WC0b01ac0580902b8d
  16. 16. 6. SUMMARY OF GVP MODULE VII Module VII includes guidance on the objectives, format and contents of the PSUR, as well as recommendations for quality systems for PSURs and training of staff members on the PSUR process. Overall Content PSURs should provide greater emphasis on analysis of case reports; to include:  scientific evaluation of the benefit-risk profile  summaries of relevant scientific/clinical data including literature searches  available sales/prescription data to calculate patient exposure The reaction terms used in the PSUR should be in accordance with the MedDRA terminology.
  17. 17. 7. HOW TO REVIEW A PSUR/PBRER Review by an experienced person who knows the drug and who knows drug safety. HIGH QUALITY /AUDITS/ INSPECTIONS • All promises and commitments made to the Health Agencies (HAs), whether in the PSUR itself or in accompanying emails or communications should be noted. Responses to HAs. • Make sure you have in hand the appropriate labels (CCSI, national labeling etc.). • The reviewer should be aware of any current concerns (safety signals, special populations, new or removed indications, any actions taken for safety reasons by the company or another health agency, any label changes for safety reasons anywhere in the world….) • Careful review of the SAEs/ADRs: • In which SOCs have most SAEs/ADRs occurred? • Any surprises or signals in the listed SAEs/ADRs? • Any surprises or signals in the unlisted SAEs/ADRs? • Any surprises or issues in the fatal SAEs/ADRs? • Are there any findings in specific patient populations as defined by disease, age, vulnerable groups etc?
  18. 18. We are safety experts, if you want to get to know us better visit us on: Azierta O síguenos en: Azierta @Azierta

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