The role of National Regulatory Authorities in technology transfer

Transcription

1 The role of National Regulatory Authorities in technology transfer A. A. Khadem B. FCH/IVB/QSS

2 Topics Vaccine development and NRA role NRA functions according to source of vaccine Vaccine regulatory process WHO prequalification principals WHO NRA strengthening, 5 step capacity building Tentative roadmap for NRA strengthening 2

3 Vaccine Development and NRA role Manufacturer/Developer National Regulatory Authority Product development Characteri zation of of candidate vaccine Preclinical/ Nonclinical testing Clinical trials Licensing PMS 3

4 National Regulatory Functions depend on vaccine source Regulatory functions Regulatory functions Regulatory system Marketing Autorization & Licensing activities Postmarketing: AEFI 4 Lot release Laboratory access Regulatory inspections Authorization & monitoring of CTs Source of vaccines UN agency Procure Produce Functions Undertaken by by WHO on on Behalf of of UN agencies or or producing countries Functions undertaken By By the the producing country

5 Applicants Dossier (manufacturer (manufacturer or or distributor) distributor) Vaccine regulatory process Pre-marketing phase Licensing/Registration= evaluation process Post Marketing phase Market distribution Product Evaluation Dossier Laboratory testing Lot Lot release AEFI surveillance 5 Quality Safety Efficacy Licensing facility GMP compliance Clinical trials (Ethical (Ethical review review process, process, GLP,GMP,GCP) GLP,GMP,GCP) Regulatory inspections Marketing Authorization (M.A.)

6 Applicants Dossier Vaccine regulatory process Pre-marketing phase Post Marketing phase Function 1 Marketing Autorization & Activities licensing Product evaluation Function 3 Lot GMP Lot release release assessment Function 4 Quality Control Laboratory access Clinical Evaluation Function 2 Postmarketing AEFIs AEFI Function 5 GMP inspections Regulatory inspections Function 6:Supervision of clinical trials Supervision of of clinical trials Marketing Authorization (M.A.) 6

7 Normal Process Applicants Dossier Vaccine regulatory process Normal Process UN agencies UN agencies Product evaluation Pre-marketing phase Function 1 Marketing Autorization & Activities licensing NRA NRA assessment assessment WHO/HQ Function 3 GMP Lot Lot release release assessment Function 4 Quality Control Laboratory access Clinical Evaluation Supervision of of clinical trials Post Marketing phase Function 6:Supervision of clinical trials Product evaluation Pre Qualification GMP GMP inspections inspections Function 2 Postmarketing AEFIs AEFI Function 5 GMP Regulatory inspections inspections Marketing Authorization (M.A.) WHO/HQ Prequalificatioqualification Pre- Approved Approved UN UN Tender/ Tender/ Decision Decision to to buy buy

8 PQ PRINCIPLES Reliance on functional NRA in the country of manufacture General understanding of production and control to ensure compliance with WHO recommendations and UN tender specifications Insurance of consistency of final Product characteristics (GMP and testing) Appropriate for target population And needs of the programme 8

9 ossible scenarios for Technology Transfe regarding NRA status 1 Fully functional NRA 2 NRA is not functional 9

10 WHO NRA strengthening activities 5 steps capacity building Output Fully functional NRA 10

11 Tentative roadmap for NRA strengthening Step 1 Step 2 Step 3 Step n Time NRA capacity building Consistent Production NRA assessment Prequalification process Fully functional NRA Target: Prequalified vaccine 11

12 Country Status: 103 assessment of vaccine regulatory systems conducted, A assessment conducted lanned NRA assessment completed Not yet conducted 12 The boundaries and names shown and the designations used on this map do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement.

13 STRENGTHENING NATIONAL REGULATORY AUTHORITIES (NRA) NRA STATUS AS OF 2010 : 59 countries have a functional NRA to regulate vaccines NRA functional NRA not functional or no data available Countries where AEFI system have documented progress or and is functionnal 13 The boundaries and names shown and the designations used on this map do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement.

14 What can be the role of NRAs in Technology transfer 14

15 THANK YOU