API Assessment Activities. Antony Fake, PhD

Transcription

1 API Assessment Activities Antony Fake, PhD

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3 Overview APIMF Procedure API PQ Procedure What is new? 3

4 Abbreviations API Active Pharmaceutical Ingredient FPP Finished Pharmaceutical Product API PQ API Prequalification APIMF Active Pharmaceutical Ingredient Master File (DMF) CPQ Confirmation of API PQ Document SRA Stringent Regulatory Authority GMP Good Manufacturing Practice PQP Prequalification of Medicines Programme 4

5 Prequalification of Medicines website 5

6 API Information An application to prequalify an FPP typically has three parts: API Information on the preparation and control of the API. + FPP Information on the preparation and control of the FPP. + S & E Safety and efficacy data, e.g. commonly a bioequivalence study. 6

7 API Information API + API-PQ APIMF or Procedure or CEP or Full dossier FPP + S & E There are 4 ways to submit API information for a FPP. 7

8 Two uses of APIMFs in PQP APIMF Procedure APIMFs API Prequalification APIMFs are used to support FPP Prequalification and API prequalification. 8

9 APIMF Procedure 9

10 APIMF Procedure FPP Manufacturer + AP RP API Manufacturer + APIMF assessment is conducted in conjunction with an FPP application 10

11 The APIMF Procedure APIMF holder FPP applicant APIMF submission to APIMF focal point Letter of Access FPP submission APIMF assessment APIMF acceptance FPP assessment FPP prequalification 11

12 Statistics All APIMFs active in PQP April 2011 April 2012 Sept 2012 Total number of active APIMFs 112 APIMFs 155 APIMFs 164 APIMFs Accepted 48 APIMFs 85 APIMFs 94 APIMFs In progress 58 APIMFs 38 APIMFs 52 APIMFs Queued for assessment 10 APIMFs 28 APIMFs 18 APIMFs 12

13 API Prequalification 13

14 Choosing your API supplier Manufacturer with APIMF and GMP compliance API Prequalification Manufacturer with an APIMF, or CEP available Manufacturer without APIMF available 14

15 What is API Prequalification? It is a scheme for API manufacturers only API Prequalification API Manufacturer There is no involvement by FPP manufacturers 15

16 What is API Prequalification? It is a scheme for manufacturers of APIs that are used in medicinal products for HIV, TB, Reproductive Health and Malaria. It seeks to verify and identify APIs that are of good quality and manufactured in compliance with GMP. It commenced as a pilot project in October It is part of the Prequalification of Medicines Programme, WHO based in Geneva. 16

17 How are APIs Prequalified Invitation Application Assessment (GMP) Assessment (Quality) Decision Publishing 17

18 Publishing List of PQ APIs Website (Public) + WHOPIRs Website (Public) Confirmation Document (Private) 18

19 WHO List of Prequalified APIs Publically available WHO application number. INN name. Date of prequalification. Name of the applicant Sites of API manufacture. The APIMF version number. The API specification version number. The primary and secondary packaging components. The assigned re-test period. The recommended storage conditions. Confirmation of API PQ document issue date Intended for: UN agencies, National medicine authorities, FPP manufacturers, public 19

20 Confirmation of API PQ document Provided to the API manufacturer for distribution at their discretion The assigned WHO application number. The INN name of the active pharmaceutical ingredient. API manufacturer company name. The API specification version number. A copy of the API specifications. The assigned re-test period. The recommended storage conditions. A copy of the assay and related substances test methods. Intended for: UN agencies, National medicine authorities, FPP manufacturers 20

21 API Prequalification Performance APIs have been prequalified for HIV (2), Malaria (15), and TB (4). 8 manufacturers have successfully PQ d one or more APIs: Anuh Pharma Ltd (1) Calyx Chemicals & Pharmaceuticals Ltd (4) Ipca Laboratories Ltd (3) Laurus Labs Pvt Ltd (2) Lupin Ltd (1) Mangalam Drugs & Organics Ltd (7) Mylan Laboratories Ltd (1) Sequent Scientific Ltd (2) 21

22 API Prequalification Performance 1 April November Sept 2012 Total number of applications Number of PQ APIs There is very positive feedback from FPP manufacturers whenever PQ of APIs is discussed. Applications and the number of prequalified APIs continues to increase. 22

23 API Assessment - Current status The number of APIMFs received and under review continues to increase, both for the APIMF procedure and for API PQ. In particular the workload from post-approval APIMF amendments increases with each accepted APIMF. Assessment workload has increases and therefore performance is under increasing pressure. 23

24 What is next? The last two years has been a period of rapid development and expansion, for example the introduction of API PQ. In the short term the primary focus is now to improve assessment performance. Formalisation of documentation and procedures. (Mandatory document formats, application forms etc) Introduction of an APIMF Amendment procedure. Introduction of new Variation guidance for API related changes. 24

25 What is next? APIMF amendments And API-related Variations 25

26 API-related changes API manufacturers who have submitted an APIMF in support of: their own Prequalified API, or the prequalification of an associated FPP Have obligations to maintain their APIMF with accurate information. And To seek approval for any API related changes (APIMF amendment) 26

27 APIMF Changes API Manufacturer APIMF Amendment Acceptance Notification to FPP manufacturer PQP API-related Variation Acceptance 27

28 Draft guidance on Variations to Prequalified FPP have been circulated. Guidance on Amendments to APIMFs is about to be circulated. Both guidance documents have: API-related changes A risk-based approach to changes. Rely upon manufacturer self-assessment of many changes. Detailed information on required supporting documents. Identical technical requirements. 28

29 API-related changes The fundamental responsibilities of API and FPP manufacturers remain the same, but the revised guidance documents Offer a reduction in the burden upon both PQP and manufacturers. Recognition of API manufacturers using the APIMF procedures. Recognition of API manufacturers using a PQ d API. 29

30 API Related Changes APIMF Amendments (DRAFT!) 30

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32 APIMF Amendment Process The success of the amendment process relies on three things: 1. Correct assessment of the change type by applicants 2. Correct submission of supporting documentation 3. Correct submission of replacement sections If all three do not occur the assessment burden will remain. Consequently, in order not to disadvantage others these requirements must be strictly enforced. 32

33 API Related Changes FPP Variations (DRAFT!) 33

34 Recognition of the APIMF procedure 34

35 Recognition of the APIMF procedure 35

36 Recognition of the use of PQ d APIs A variation is only required if there is a change to the CPQ 36

37 Prequalification of Medicines website 37

38 Further information The PQ website is a good source of information, please read. AND, ALSO Please me (or visit) if you have any questions. Fakea@who.int One could save you a lot of time. 38