Outline. World Health Organization 14 July, Strengthening for capacity to regulate influenza vaccines

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1 Strengthening for capacity to regulate influenza vaccines Outline WHO reorganization and Regulatory Systems Strengthening (RSS) Team WHO Regulatory Systems Strengthening Department of Essential Medicines and Health Products Presented by: Dr Claudia P Alfonso 7 May 2014, Geneva, Switzerland WHO capacity building and harmonization approach Progress on regulatory functionality and influenza vaccine prequalification in GAP countries Regulatory capacity building under the Pandemic Influenza Preparedness (PIP) Framework 2 Regulatory Systems Strengthening in the WHO HIS: Health Systems and Innovation Hierarchy EMP: Essential Medicines and Health Products RHT: Regulation of Medicines and Other Health Technologies PAU: Policy, Access and Use Director General (M. Chan) The WHO Regulatory Systems Strengthening Team NRA assessment Group (Leader L. Belgharbi) RSS Coordinator (N. Dellepiane) Capacity building & Harmonization Group (Leader S. Azatyan) PHI: Public Health, Innovation and Intellectual Property HIS Cluster (M.P. Kieny) SAV: Safety and Vigilance U. Kartoglu S. Jones A. Bellah A. Prat R. Ostadali RSS: Regulatory Systems Strengthening TSN: Technologies Standards and Norms EMP (C. De Joncheere) Department PQT: Prequalification RHT (L. Rago) PAU (G. Forte) PHI (Z. Mirza) A. Khadem S. Wahab L. Brown M. Yap P. Guillot C. Alfonso 3 SAV RSS TSN PQT (C. Ondari) (N. Dellepiane) (D. Wood) (?) We are here! 4 1

2 The RSS Vision The RSS Mission All Members States have regulatory systems to ensure that all medical products and other health technologies meet internationally recognized standards of quality, safety and efficacy Strengthen capacity of regional/sub-regional and/or national regulatory systems in order to contribute to improved access to medical products and other health technologies of assured quality, safety and efficacy 5 6 Capacity Building and Harmonization Approach Essential regulatory functions required for vaccines used in national immunization programmes Gap analysis Institutional Development Plan Address gaps Monitor progress & impact Assessment A plan for addressing gaps identified Provide technical support Training IDP follow-up Re-assessment Global Learn ing Opport unities Incounty work shops 1.NATIONAL REGULATORY SYSTEM Technic al Support & on site consulta nts Targeted Regulatory Functions 2.REGISTRATION AND MARKETING AUTHORIZATION 3.LICENSING ACTIVITIES 4.POST-MARKETING SURVEILLANCE ( + LOT RELEASE FUNCTION) 5.OVERSIGHT OF CLINICAL TRIALS 6.INSPECTIONS AND ENFORCEMENT ACTIVITIES 7.LABORATORY ACCESS AND TESTING 8.VIGILANCE AND RISK MANAGEMENT 9.CONTROL OF PROMOTION AND ADVERTISING Place ment, joint review, twining, others Regulatory system Marketing authorization Pharmaco-vigilance Lot release Laboratory access Regulatory inspections Oversight of clinical trials VACCINE SOURCE FUNCTIONS UN Agency Procure Produce NOT APPLICABLE 7 10.CONTROL OF NARCOTICS, PSYCHOTROPIC SUBSTANCES AND PRECURSORS 11.PHARMACEUTICAL PERSONNEL 8 2

Regulatory Systems Strengthening Programme NRA Status Vaccine Producing

Building Globally *National Control Laboratory, **Expanded Programme on

Organization/Essential Medicines and Health Products, as of 4 March 2013

Immunization 12 Vaccine Manufacturers Source: World Health 3

3 Regulatory Systems Strengthening Programme NRA Status Vaccine Producing Countries 2006 Regulatory Systems Strengthening Programme NRA Status Vaccine Producing Countries NRA Trainings Conducted NRA Capacity Building Globally *National Control Laboratory, **Expanded Programme on Immunization, Vaccine Manufacturers 11 Source: World Health Organization/Essential Medicines and Health Products, as of 4 March 2013 *Global Training Network, **National Control Laboratory, Expanded Programme on Immunization 12 Vaccine Manufacturers Source: World Health Organization/Essential Medicines and Health Products, as of 4 March

NRA Trainings per WHO Regions Regulatory Capacity Building for Influenza Vaccines GAP Countries 2006-2013 Regulator y Function Marketing Authorization Activity

NIBSC, UK QC training and manufacturing, 2008-2010, NVI, Netherlands Participation in international proficiency study, 2012-2014, GAP countries GMP inspection

Korea Fundamentals of GMP Influenza Vaccine Manufacturing, 2013, USA Regulatory Inspection Risk Approach, 2013, Brazil 30 regulators 10 regulators 22 NRAs and

Organization/Essential Medicines and Health Products, as of 4 March 2013 Clinical trials Clinical trial design for combination & influenza vaccines workshop,

Training and Education Center, North Carolina State University, August 2013 WHO technology transfer to establish influenza vaccine manufacturing capacity / NRAs

Africa, and Vietnam AFR South Africa 0 0 AMR Brazil, Mexico Brazil Brazil EMR Egypt, Islamic Rep.

4 NRA Trainings per WHO Regions Regulatory Capacity Building for Influenza Vaccines GAP Countries Regulator y Function Marketing Authorization Activity Training on quality assessment of influenza vaccines, 2013, USA Participants 6 countries Lot release & lab access Regulatory Inspections QC training, , NIBSC, UK QC training and manufacturing, , NVI, Netherlands Participation in international proficiency study, , GAP countries GMP inspection training, 2011, S. Korea Fundamentals of GMP Influenza Vaccine Manufacturing, 2013, USA Regulatory Inspection Risk Approach, 2013, Brazil 30 regulators 10 regulators 22 NRAs and manufaturers 36 regulators 13 *National Control Laboratory, **Expanded Programme on Immunization, Vaccine Manufacturers Source: World Health Organization/Essential Medicines and Health Products, as of 4 March 2013 Clinical trials Clinical trial design for combination & influenza vaccines workshop, 2008, Switzerland GCP inspection training, 2011, S. Africa 19 regulators US BARDA & CBER-Sponsored Training Fundamentals of cgmp Influenza Vaccine Manufacturing Biomanufacturing Training and Education Center, North Carolina State University, August 2013 WHO technology transfer to establish influenza vaccine manufacturing capacity / NRAs assessed for vaccine pre-qualification ( PQ) WHO Region GAP country* NRA functional for PQ** Happy regulators from Egypt, India, Indonesia, Serbia, S. Africa, and Vietnam AFR South Africa 0 0 AMR Brazil, Mexico Brazil Brazil EMR Egypt, Islamic Rep. Iran 0 Egypt, Iran EUR Serbia, Romania, Kazakhstan 0 0 SEAR India, Indonesia, Thailand Indonesia, India India, Indonesia, Thailand WPR China, Rep. Korea, Viet Nam Rep. Korea China, Rep. Korea Total 4/14 (29%) 8/14 (57%) 15 * **Vaccine producing countries, 4

Country Manufacturer NRA-approval (Date) Potential production capacity (M doses) Brazil Instituto Butantan Seasonal Vacina Influenza, fragmentada e inativada Seasonal (40) (Sep 2012) Pandemic with

5 Country Manufacturer NRA-approval (Date) Potential production capacity (M doses) Brazil Instituto Butantan Seasonal Vacina Influenza, fragmentada e inativada Seasonal (40) (Sep 2012) Pandemic with adjuvant (160) China Changchun BCHT Biotechnology Co. Not yet 0 Egypt Egyptian Company for the Production Not yet Seasonal (0.5) of Vaccines, Sera and Drugs (EgyVac/ Pandemic (20) Vacsera) India Serum Institute of India Pandemic Nasovac, H1N1 LAIV (Jul 2010) Seasonal (8) Pandemic Enzavac, H1N1 inactivated (Jul 2010) Pandemic LAIV (20) Seasonal trivalent Nasovac-S LAIV (Jan 2014) Indonesia Biofarma Seasonal Flubio fill/finish, bulk from Biken, (Jun Seasonal (4 ) 2009) Pandemic with adjuvant (16-32) Iran Razi Institute Not yet 0 Mexico Laboratorios de Biológicos y Reactivos Not yet Seasonal (30) de México (BIRMEX) Pandemic filling capacity (120) Romania Cantacuzino Institute of Sera and Vaccines Pandemic CANTGRIP, H1N1 IIV spli (Nov 2011) Seasonal (2-2.5) Pandemic with adjuvant (37.5) Rep. Korea Green Cross Pandemic split H1N1 GC FLU (Oct 2009) Pandemic GreenFlu-S Plus, split with MF59 (Jan 2010) Seasonal GC Flu (Apr 2011) Seasonal (15) Pandemic (180) Serbia Torlak Institute Not yet Seasonal (0.5 ) Pandemic (1) South Africa Biovac Not yet Seasonal (2.5, max 15) Thailand Viet Nam Kazakhstan Government Pharmaceutical Organization (GPO) Institute of Vaccines and Medical Biologicals (IVAC) Research Institute for Biological Safety Problems (RIBSP) Pandemic: depending on CSL bulk supply (144) Pandemic FLU VAC, H1N1 LAIV pandemic use only Seasonal IIV (10), LAIV (1) in adults (Jul 2011), extended to yrs (Mar2012) Pandemic (30-60) Not yet Seasonal (0.5) Pandemic (1.5) Not yet Seasonal (6-7) Pandemic (21) depending on immunogenicity; with adjuvant (42) Manufactures in GAP countries with WHO prequalified influenza vaccines Country Manufacturer WHO-PQ (Date) Potential production capacity (Million doses) India Serum Institute of India Rep. Korea Green Cross Pandemic Nasovac (Nov 2012) Pandemic vaccine, H1N1 GC Flu (May 2010) Seasonal trivalent split vaccine, GCFlu-S single and multi-dose final container presentations (2011 and 2012) Pandemic LAIV (20) Pandemic (15) Seasonal (30) Pandemic Influenza Preparedness Framework WHA 2011 PIP Framework website: Member States, industry, WHO, and other stakeholders to implement a global approach to pandemic influenza preparedness and response Improve and strengthen the sharing of influenza viruses with human pandemic potential Increase access of developing countries to vaccines and other pandemic related supplies 30% Pandemic Influenza Preparedness (PIP) Framework Partnership Contributions (PC) (Implementation Plan - Introduction) Proportional distribution of PC (EB131) 70% Prepardness Response 10% Preparedness (70%) 20% 70% Planning for response: - Regulatory Capacity building - Risk Communications - Planning for Deployment Lab &Surveillance (70%) Burden of Disease (10%) Planning for Response (20%) 19 TITLE from VIEW and SLIDE MASTER July 14,

World Health Organization July, 2014 14 Outcome Output 1 Regulatory Capacity Building Countries with weak or no regulatory capacity will be able to regulate influenza products including vaccines,

6 World Health Organization July, Outcome Output 1 Regulatory Capacity Building Countries with weak or no regulatory capacity will be able to regulate influenza products including vaccines, antivirals and diagnostics, and to accelerate national approval of these commodities in case of an influenza pandemic Guidelines on regulatory preparedness for non-vaccine producing countries that enables them to expedite approval of influenza vaccines used in national immunization programs and/or deployed by UN agencies in response to a pandemic emergency are developed PIP PC Target Countries, Regulatory Capacity Building Output 2 NRA capacity to regulate influenza products including vaccines, antivirals and diagnostics is strengthened Output 3 Regulatory processes to accelerate approval of influenza vaccines, antivirals and diagnostics during public health emergency are incorporated into deployment plans for pandemic influenza products The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the REGULATORY CAPACITY BUILDING TARGET COUNTRIES part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the (16 countries, subject to funds) delimitation of its frontiers or boundaries. Dotted and dashed lines on maps represent approximate border lines for which there may not yet be full agreement. WHO All rights reserved. 21 AVAREF 15 Oct 2013 Entebbe 22 Source: WHO/PED, PIP Secretariat, 04 April 2014 Essential regulatory functions required for vaccines used in national immunization programmes Essential vaccine regulatory functions baseline* Vaccine source: UN Agency** FUNCTIONS UN Agency Procure Produce Regulatory system Marketing authorization Pharmaco-vigilance Lot release Laboratory access Regulatory inspections Oversight of clinical trials VACCINE SOURCE PIP PRIORITY COUNTRIES (11/16***) Average % Lowest % Highest % No. Countries < 50% Regulatory System * As per WHO NRA assessment against published indicators ** Source of pandemic influenza vaccines during public health emergencies Marketing Authorization *** 10/11 PIP countries were assessed between ; 1/11 PIP countries was assessed in Pharmaco- Vigilance NOT APPLICABLE

WHO recommendations per regulatory function 2012 NRA Institutional Development Plans (IDPs) of six AFR countries Strengthening Capacity to Regulate Influenza Vaccines Summary Overall regulatory

NRAs in GAP countries doubled (2006-2013); global influenza vaccine production & registration increased; progress to be made and sustained Expedited procedure and WHO health product

7 WHO recommendations per regulatory function 2012 NRA Institutional Development Plans (IDPs) of six AFR countries Strengthening Capacity to Regulate Influenza Vaccines Summary Overall regulatory capacity with simultaneous attention to influenza health products favors sustainability Proper national regulatory systems enable countries to respond better to public health emergencies Functional NRAs in GAP countries doubled ( ); global influenza vaccine production & registration increased; progress to be made and sustained Expedited procedure and WHO health product prequalification facilitate regulatory common approach during pandemics Improvements in regulatory systems, marketing authorization and pharmaco-vigilance functions in non-producing countries envisioned Gracias 7

Progress under GAP Pillar 2 "Increase Production Capacity" Contribution of the WHO Technology Transfer Programme. Martin Friede

Progress under GAP Pillar 2 Increase Production Capacity Contribution of the WHO Technology Transfer Programme. Martin Friede Progress under GAP Pillar 2 "Increase Production Capacity" Contribution of the WHO Technology Transfer Programme Martin Friede Global influenza vaccine production capacity since 2006 Cantacuzino Romania