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. Artemisinin combined medicines, Kampala, February 2009 2 |2 | Synopsis  Sharing information  Goals  Tools/Ways -in Europe among authorities with the public -in WHO Prequalification Programme

3. Artemisinin combined medicines, Kampala, February 2009 3 |3 | Sharing information  Goals  Improving health protection  making regulatory processes more efficacious  avoiding duplication of work  Improving transparency

4. Artemisinin combined medicines, Kampala, February 2009 4 |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. Artemisinin combined medicines, Kampala, February 2009 5 |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. Artemisinin combined medicines, Kampala, February 2009 6 |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. Artemisinin combined medicines, Kampala, February 2009 7 |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 statements on general, mostly technical issues  CHMP-Summaries of opinions on positive recommendations for medicinal products  European Public Assessment Reports (EPARs) on approved products  Product safety announcements on pharmacovigilance issues.

8. Artemisinin combined medicines, Kampala, February 2009 8 |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. Artemisinin combined medicines, Kampala, February 2009 9 |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. Artemisinin combined medicines, Kampala, February 2009 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. Artemisinin combined medicines, Kampala, February 2009 11 | Assessment outcomes Europe (V)  How to get the information? http://www.emea.europa.eu

12. Artemisinin combined medicines, Kampala, February 2009 12 | How to get the information  http://www.emea.europa.eu

13. Artemisinin combined medicines, Kampala, February 2009 13 | How to find an EPAR

14. Artemisinin combined medicines, Kampala, February 2009 14 |

15. Artemisinin combined medicines, Kampala, February 2009 15 | Atripla

16. Artemisinin combined medicines, Kampala, February 2009 16 |

17. Artemisinin combined medicines, Kampala, February 2009 17 | How to find an EPAR

18. Artemisinin combined medicines, Kampala, February 2009 18 | 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

19. Artemisinin combined medicines, Kampala, February 2009 19 | Assessment outcomes WHO (I)  WHOPAR-Guideline

20. Artemisinin combined medicines, Kampala, February 2009 20 | Assessment outcomes WHO (II)

21. Artemisinin combined medicines, Kampala, February 2009 21 | Assessment Outcomes WHO (III)

22. Artemisinin combined medicines, Kampala, February 2009 22 | 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

23. Artemisinin combined medicines, Kampala, February 2009 23 | Assessment outcomes WHO (V)  How to get the information? http://www.who.int/pq

24. Artemisinin combined medicines, Kampala, February 2009 24 |

25. Artemisinin combined medicines, Kampala, February 2009 25 | How to find an WHOPAR

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27. Artemisinin combined medicines, Kampala, February 2009 27 |