Experience with obtaining GMP certification and WHO prequalification programme

Transcription

1 Experience with obtaining GMP certification and WHO prequalification programme V. Faillat Proux 1 Mumbai September 29, 2009

2 COARSUCAM / ASAQ Winthrop ArteSunate + AmodiaQuine, a fixed dose combination For a correct and safe use of the product To simplify treatment regimens To ensure treatment effectiveness and prevent future resistance to ACT 2

3 A fixed dose combination adapted to patients needs 3 strengths 25mg/67.5mg 3 50mg/135mg 100mg/270mg

4 A fixed dose combination adapted to patients needs Packed in 4 types blister 4

5 A fixed dose combination adapted to patients needs for 4 patients groups INFANT 4.5kg to <9 kg (2 11 months) 5 TODDLERS 9kg to <18kg (1 to 5 years) CHILDREN 18kg to <36kg (6 to 13 years) ADOLESCENT ADULT 36kg (14 years and above)

6 2 brandnames Artesunate Amodiaquine Winthrop COARSUCAM Impact Malaria COARSUCAM 6

7 Registration status ASAQ is registered in 25 endemic countries And prequalified since October

8 The prequalification and GMP certification experience Presubmission meeting: Dec Submission : Feb First round of questions : Jul Inspection: Jun New inspection Jan GMP publication : Feb Second round of question: May 2008 Third round of questions : Aug Fourth round of questions : Oct Prequalification : 14 Oct

9 It s not finished! 9

10 But it is not finished! 10

11 The prequalification and GMP certification experience Request for WHOPAR applicant contribution: First round of questions/modifications : January 2009 Second round of questions/modifications: Third round of questions/modifications : February 2009 February 2009 Fourth round of questions/modifications: March 2009 WHOPAR final version 31 March October 2008

12 The prequalification and GMP certification experience In case of any modification, the file should be updated and reviewed by the WHO Every 5 years, requalification 12

13 The prequalification experience Lessons learned The involvement of the company/employees in such process The importance of early meeting with WHO to confirm points not cover by the current guidelines The importance of the presubmission meeting 13

14 The prequalification experience Lessons learned A long process due to the product status fixed dose combination never prequalified prequalification process adapted to generics or products already registered by a stringent authority A long process but with quick review times A long process justified by the high quality level requirements on both dossier and inspection 14

15 The prequalification experience Lessons learned Take care of long process that may open the door to parallel procedures without full guarantee (ERP) Documentation required not always clearly defined 15

16 The prequalification experience The content of the file File submitted under CTD format Additional format report PQIF/BTIF APIMF process Risk Management Plan 16

17 The prequalification experience The content of the file Lessons learned: Close link between inspection and file assessment, not clear in the procedure => data or documents not required in any guidance Requirement of specific reports (time consumming) APIMF but no information about the status of the API manufacturer file during the process Be creative 17

18 The prequalification experience Prequalification is not a marketing authorization, nor a manufacturing authorization, nor an importation licence. Legal and required authorizations/gmp certifications should be obtained additionally country by country. It is not a key to open regulations doors. 18

19 The prequalification experience This may lead to difficulties: Artemisinin: starting material status in the PQ file, but for some authorities GMP status is required to import artemisinin. Requirements from WHO to update leaflet, but variation or notification should be applied in each country. Management of the various inspections 19

20 Thank you for your attention 20