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Information outcomes from regulatory processes

Information outcomes from regulatory processes. Regine Lehnert. Training workshop: Regulatory requirements for registration of Artemisinin based combined medicines and assessment of data which are submitted to regulatory authorities, February 2009. Synopsis. Sharing information Goals

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Information outcomes from regulatory processes

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  1. Information outcomes from regulatory processes Regine Lehnert Training workshop: Regulatory requirements for registration of Artemisinin based combined medicines and assessment of data which are submitted to regulatory authorities, February 2009

  2. Synopsis • Sharing information • Goals • Tools/Ways • in Europe • among authorities • with the public • in WHO Prequalification Programme

  3. Sharing information • Goals • Improving health protection • making regulatory processes more efficacious • avoiding duplication of work • Improving transparency

  4. Sharing information in Europe (I) • EMEA - scope • scientific resources • of 40 competent authorities • in 30 countries • with over 4,000 European experts • Collaboration with WHO, ICH, European Pharmacopoeia

  5. Sharing information in Europe (II) • EMEA - tasks • evaluation of applications for European marketing authorisation for medicinal products • monitoring of safety through pharmacovigilance network • stimulating pharmaceutical innovation and research by scientific advice and protocol assistance.

  6. Sharing information in Europe (III) • Networking Tools • Scientific discussions/exchanges in each procedure • Regular assessors‘ meetings • Telematics • EudraServices, e.g. EudraLink • EudraData Warehouse, e.g. EudraCT, EudraGMP, EudraVigilance

  7. Assessment outcomes Europe (I) • EMEA – publications on medicinal products • EMEA Press releases, e.g. on committee meeting outcomes, on withdrawals of applications and on refusals • Public statementson general, mostly technical issues • CHMP-Summaries of opinions on positive recommendations for medicinal products • European Public Assessment Reports (EPARs)on approved products • Product safety announcementson pharmacovigilance issues.

  8. Assessment outcomes Europe (II) • What is an EPAR? • Scientific conclusion reached by the CHMP • Summary on the grounds for opinion • Information for the public after deletion of confidential data • Who is in charge of the EPAR? • Drafted by EMEA (SOP in place) • Usually involvement of Rapporteur • Agreement of Marketing Authorisation Holder

  9. Assessment outcomes Europe (III) • EPAR –Structure • Summary for the public • All authorised presentations • Scientific discussion • Procedural steps taken before authorisation • Steps taken after authorisation • Product Information

  10. Assessment outcomes Europe (IV) • Product Information • Annex I - Summary of product Characteristics • Annex IIA - Marketing Authorisation Holder responsible for Batch Release • Annex IIB - Conditions of the Marketing Authorisation • Annex IIIA - Labelling • Annex IIIB - Package Leaflet

  11. Assessment outcomes Europe (V) • How to get the information? http://www.emea.europa.eu

  12. How to get the information • http://www.emea.europa.eu

  13. How to find an EPAR

  14. Atripla

  15. How to find an EPAR

  16. Assessment outcomes Europe (VI) • Public assessment reports by National regulatory authorities - in English • legal obligation to make information on medicinal products publicly available • Guidance and template: http://www.hma.eu/uploads/media/BPG_PAR.pdf • Examples: • United Kingdom: MHRA • The Netherlands: CBG-MEB • Norway: Statens legemiddelverk

  17. Assessment outcomes WHO (I) • WHOPAR-Guideline

  18. Assessment outcomes WHO (II)

  19. Assessment Outcomes WHO (III)

  20. Assessment outcomes WHO (IV) • Structure • Part 1: Abstract • Part 2: All accepted presentations • Part 3: English package leaflet • Part 4: English summary of product characteristics • Part 5: English labelling • Part 6: Scientific discussion • Part 7: Steps taken for prequalification • Part 8: Steps taken after prequalification

  21. Assessment outcomes WHO (V) • How to get the information? http://www.who.int/pq

  22. How to find an WHOPAR

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