1. FCH/IVB/QSS, Lahouari Belgharbi Global & Regional overview on the WHO Programme on Strengthening National Regulatory Authority (NRAs) 19 th ACCSQ-PPWG meeting 2-6 July 2012, Bangkok, Thailand 19 th ACCSQ-PPWG meeting 2-6 July 2012, Bangkok, Thailand Lahouari Belgharbi, Scientist, WHO HQ, Geneva Vaccines

2. FCH/IVB/QSS, Lahouari Belgharbi The Vaccine Pipeline

3. FCH/IVB/QSS, Lahouari Belgharbi

4. เงินลงทุน WHO USD 1.9 billion immunization (2006-2011)

5. Vaccine producing 1990: 63 countries 2010: 44 countries Vaccine demand increases While producing countries decreased

6. FCH/IVB/QSS, Lahouari Belgharbi Pays producteurs de vaccins 1990: 63 countries 2010: 44 countries Majors vaccines producing countries China……………..23% India......………….30% Indonesia………..10% S.Korea……..…....5% Brazil……………....3% Bulgaria……………5% France……………..8% Russia……………..2% Italy………………..3% Belgium…………...5% Other countries….5% Thai ….X %..... 4 ASIAN countries account for 68% of global vaccine production

7. FCH/IVB/QSS, Lahouari Belgharbi The UNICEF : buying 40% of the global volume of vaccine doses, mainly EPI vaccines, but representing only 5% of market value 40% 5% VolumeValue Global EPI Vaccines: (1) Diphtheria (2) Tetanus (3) Pertussis (Whooping cough) (4) Poliomyelitis (5) TB (6) Measles and (7) Hepatitis B

8. FCH/IVB/QSS, Lahouari Belgharbi Vaccine producers in the market (source: Mercer study to GAVI, 2002) US multinationals European multinationals OECD locals Emerging suppliers Developing country local Product range NarrowBroadNarrowNarrow- Moderate Narrow Scale LowHighLowModerate-HighLow-High Customer focus Mostly high income All buyer segments Mostly in country In country and other low moderate income buyers All in country R&D activity High LowLow-ModerateLow Producers Merck, WyethSanofi-Pasteur (France), GSK (Belgium), Chiron (Italy) SSI (Denmark), CSL (Australia), Powderject SII (India), Biofarma (Indonesia), Green Cross (Rep.Korea) State owned producers: China, Egypt, Mexico, Vietnam, Thailand

9. FCH/IVB/QSS, Lahouari Belgharbi การวางแผนงานเพื่อ Global challenges 1.Specificity of Biologicals to be addressed in most pharmaceutical regulation to anticipate regulatory requirements to ease vaccine introduction 2.Use of existing technical/scientific guidelines rather than producing new one that increase duplication and insistencies among member states 3.Demand for vaccines increased due to new initiatives and global coalition efforts 4.Public awareness about vaccines safety, quality and efficacy is increasing through media and internet and social networks.

10. FCH/IVB/QSS, Lahouari Belgharbi การวางแผนงานเพื่อ Global challenges 5.Implementation and enforcement of standards promoted by developed countries may reduce capacity of developed countries 6.Quality control systems established in countries need increased investment and sustainable support to be able to meet new demand on vaccine testing. 7.Domestic production in developing countries not consistent in volume and quality. 8.Shift in vaccine market and increase segmentation.

11. FCH/IVB/QSS, Lahouari Belgharbi How quality of vaccines is met? WHO Standards: GMP ASEAN PIC/S Vaccine regulation…

12. FCH/IVB/QSS, Lahouari Belgharbi QualityEfficacySafety 1. License facility to manufacture vaccines 2. Enforce Good Manufacturing Practices (GMP) 3. Enforce and monitor recall procedure 4. Investigate complaints 1. Authorize clinical trials (CT) -Review of CT against national regulations - Ethical review, GLP, GCP, GMP. 2. Providing input (epidemiology and bio-statistic) to ensure highest standards of CT method. 3. Involve product expert in reviewing CT Stop or suspend CT if not meeting national regulations 4. Ensure that any AEFI occurring during CT is fully documented and reported What NRA does to safeguard National Immunization

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

14. FCH/IVB/QSS, Lahouari Belgharbi Source of vaccines UN agency Procure Produce PRIORITIES FOR IMPLEMENTATION to ensure that all EPI vaccines are of assured quality Regulatory functions Regulatory functions CTs : Clinical trials, UN: United Nations, AEFI: Adverse Events Following Immunization Marketing Autorization & Licensing activities Laboratory access Regulatory inspections Lot release Authorization & monitoring of CTs Postmarketing: AEFI Regulatory system for countries that conduct clinical trials Functions undertaken in producing Countries with functional NRA

15. Sources of Vaccines ?

16. Context: Emerging economies are becoming a major actor of the vaccine market % Share by volume % Share by value *2011 – 2012 Data based on awards already made Developing countries Industrialized countries 50

17. FCH/IVB/QSS, Lahouari Belgharbi Developing countries with emerging vaccine production or high potential to account for 80-70% of the global production Brazil South Africa China MexicoSenegal Indonesia India Viet Nam Russia Serbia Iran Egypt Cuba Countries with WHO prequalified vaccines

18. FCH/IVB/QSS, Lahouari Belgharbi Potential Collaboration between ASEAN/PPWG and WHO in the area of Vaccine Regulation 2012 PIC/S vs NRA Registration

19. FCH/IVB/QSS, Lahouari Belgharbi Activities planned and supported by WHO and partners institutions Areas of cooperation between NRAs Themes Good Regulatory Practices (GRP), guidance on legislation and regulations, international assessment of NRAs, Quality management system, Regulatory framework 1 E-learning, twining with foreign institutions, exchange programme, in country training, technical support, Observed and coach GMP audits Capacity building to strengthen regulatory systems 2 Use of CTD, promote e-governance, exchange and sharing assessment reports, parallel review, observed and coached audits, memorandum of cooperation, address duplication of scientific assessments to reduce burden and costs, and speed up regulatory decision. Harmonization of regulatory initiatives, standards, and sharing of information 3 Strategic NRA forum, NRA regional alliance, nter-country meeting, NRA assessment indicators meeting, network of regional references laboratories, DCVNM, GAVCS, ECBS, ICDRA. International and regional coordination and networking 4 1 st WHO NRA strategic forum, 3-5 May 2011, Bangkok.

20. FCH/IVB/QSS, Lahouari Belgharbi Activities planned and supported by WHO and partners institutions Areas of cooperation between NRAs Themes Increase exchange with industry to address duplication, redundancy of process, bureaucracy, cost increase and ensure fair treatment and competition among applicants. Consultation with industry 5 Coordination of international and bilateral cooperation support strategic areas and enhance government commitment to support regulatory agencies Consultation with donors and technical agencies or stakeholders 6 Publication of success stories, best practices to promote Good Regulatory Practices (GRP), exchange programme and building in country learning capacity Advocacy and Communication 7 Coordination and mapping of international and bilateral aid to enhance support to strategic areas and priorities activities Resource mobilization and coordination 8 1 st WHO NRA strategic forum, 3-5 May 2011, Bangkok.

21. FCH/IVB/QSS, Lahouari Belgharbi WHO support to vaccine evaluation for marketing authorisation of dengue vaccine Planning Agreement with NRAs & Manufacturers Selection of NRAs Mentors/mentorees Development of training material Product evaluation Marketing Authorisation 20122013 2014-15

22. FCH/IVB/QSS, Lahouari Belgharbi Activities planned and supported by WHO and partners institutions Areas of cooperation between NRAs Themes Dengue, bottlenecks in vaccine regulation, CTD Consultation with industry 5 Support to vaccine producing countries (developing and middle income): China, India, Thailand, Viet Nam, Indonesia through Functional NRAs (Australia, China, Japan and S.Korea) Consultation with donors and technical agencies or stakeholders 6 WHO book to be published in early 2014 to document Global coalition efforts to ensure vaccine quality through NRAs, Global NRA strategic plan, Posters on NRAs, Publication of success stories articles from India, Thailand, Indonesia, China and Viet Nam, WHO NRA country profile Advocacy and Communication 7 Coordination with BMGF; GAVI and bilateral aid (Korea, Japan and Australia) to support ASEAN developing countries to strengthen their NRAs. Plan to involve ADB, UNICEF, and other partners. Resource mobilization and coordination 8 World Health Organisation : Areas of cooperation 2012-2013.

23. FCH/IVB/QSS, Lahouari Belgharbi How to move forward to develop capacity building activities in ASEAN member states Organise a cooperation meeting with WHO to : 1.Discuss the integration plan of NRA institutional Development Plan (IDP) into the ASEAN agenda ‘s capacity building programme, 2.Map all capacity building activities such as : 1.Governance including Legal framework, institutional regulation and technical guidelines development, 2.Learning and training activities 3.E-governance 4.Internal expertise in product evaluation, clinical trial, inspections, regulatory oversight, pharmacovigilance, testing, advocacy, communication, economic of regulation, performance indicators development,

24. FCH/IVB/QSS, Lahouari Belgharbi How to move forward to develop capacity building activities in ASEAN member states Organise a cooperation meeting with WHO to : 3.Develop a joint workplan to address implementation including planning, technical support and financial support through: 1.Recruitment of expert to map the current activities in both organization (WHO and ASEAN) and to provide a report for discussion of the coordination workplan, 2.Publish a report and an biennium workplan that detailed activities: planned, responsibilities, performance indicators, milestones, reporting and update mechanisms including accountability framework, estimated budget, technical support and fundraising needs. 3.Develop and publish joint report (WHO and ASEAN) to document the progress and impact to WHO and ASEAN relevant meetings

25. FCH/IVB/QSS, Lahouari Belgharbi 19 th ACCSQ-PPWG Meeting 2-6 July 2012, Bangkok, Thailand ได้รับที่จะนำเรื่อง Vaccine มา เตรียมการ (ACTD) ใน ASEAN ยาแผน ปัจจุบัน Thank you