1. World Health Organization, Beijing China WHO-Gates project on TB improvement in China 30 March 2010 Christina Foerg-Wimmer, PhD. WHO China Office

2. World Health Organization, Beijing China Gates project on TB control in China: To substantially improve TB control in China. Project background

3. World Health Organization, Beijing China Project background – Gates projects on TB control in China China MoH – Gates Foundation TB project: Use of Innovative Tools and Delivery Approaches to Improve TB control in China (5 years) SFDA – Gates Foundation Subproject: China anti-tuberculosis FDC drug quality assurance (2 years) WHO – Gates Foundation Project: To substantially improve TB control in China by increasing national capacity to produce fixed-dose combination (FDC) anti-TB medicines of assured quality and to regulate TB FDC drugs (18 months)

4. World Health Organization, Beijing China TB situation in China China is the country with the world’s second largest TB epidemic, with 1.3 million new TB patients (all forms) every year. The most serious challenge facing the control of TB in China is the emergence of a MDR-TB epidemic. To date, the standard treatment consists of first-line TB drug treatment for all patients. To prevent that patients with drug-resistant TB are receiving improper or inadequate treatment, fixed-dose combination (FDC) TB drugs in national TB control programs are being highly promoted. FDC TB drugs are easier to handle and can help prevent the development of drug-resistant TB.

5. World Health Organization, Beijing China TB FDC demand Global situation: Global needs for FDCs are not satisfied yet (not many competitors existing), thus export opportunities for quality assured FDCs are high. For international procurement, increased attention will be paid to the quality of products; international standards are expected.

6. World Health Organization, Beijing China TB FDC demand Global market considerations for anti-TB drugs Source: Global Drug Facility (GDF), UNITAID The Global market for anti-TB drugs is forecasted to reach US$ 600 - 700 million in 2010. The combined public and private market for first-line anti-TB drugs is forecasted to reach 462 million US$ (with public/tender market ~183 million US$). The global market for second-line anti-TB drugs will reach 120 million US$.

7. World Health Organization, Beijing China TB FDC demand Situation in China: According to MoH/CDC guideline, the predicted consumption of TB FDCs will increase approximately 10 times in the years 2010 -2013 (MoH/CDC guideline). Additionally, there will be also considerable demand from non-CDC users, once TB FDCs are available.

8. World Health Organization, Beijing China TB FDC demand *Pacific Health Summit, USA, June 2009. 4 Estimated from self-reported sales numbers by FDC manufacturers (Huangban, Hongqi, Nanyang). Source: Interviews and Global TB Control 2009

9. World Health Organization, Beijing China Project support WHO – Gates Foundation Project: To substantially improve TB control in China by increasing national capacity to produce fixed-dose combination (FDC) anti-TB medicines of assured quality and to regulate TB FDC drugs (18 months)

10. World Health Organization, Beijing China WHO Project activities Objectives: Pharmacopeia: Pharmacopeia: Support the Chinese Pharmacopoeia Committee (ChPC) in revising or drafting monographs of FDC anti-TB dosage forms and of their respective APIs for inclusion in the Chinese Pharmacopeia. GMP: GMP: Support 4 manufacturers of FDC anti-TB medicines in implementing WHO GMP standards, and in meeting requirements for participating in the WHO PQ program Post-market surveillance: Post-market surveillance: Provide technical support to quality control testing lab for anti-TB medicines produced in China.

11. World Health Organization, Beijing China Project support The WHO and SFDA project focuses on support to FDCs manufacturers in their effortThe WHO and SFDA project focuses on support to FDCs manufacturers in their effort –to implement internationally accepted GMP standards and –have available regulatory dossiers, which satisfy WHO requirements. This will help FDC manufacturers to be prepared for implementation of revised GMP standards planned to be soon binding in China.This will help FDC manufacturers to be prepared for implementation of revised GMP standards planned to be soon binding in China. Additionally, it will substantially increase chance to be successful when exporting FDCs outside China and/or when applying for WHO prequalification. Additionally, it will substantially increase chance to be successful when exporting FDCs outside China and/or when applying for WHO prequalification.

12. World Health Organization, Beijing China Project support No direct financial support to manufacturers through this project but Technical Assistance (TA), including Free of charge support: to achieve quality assured production of TB FDC drugs and thus, to extend portfolio, strengthen role on domestic market and increase export opportunities to implement new GMP standards (draft of new GMP standards already published by SFDA) to move towards WHO prequalification. WHO prequalification functions as a gate-keeping mechanism to enter international tenders and procurement is growing to better understand GMP and data requirements for FDCs which is of benefit not only for FDC but all other drug production

13. World Health Organization, Beijing China Project activities Manfacturers participating in the project commit themselves to: Produce or develop TB FDCs (in line with WHO recommended formulatios)Produce or develop TB FDCs (in line with WHO recommended formulatios) Submit these medicines for WHO PrequalificationSubmit these medicines for WHO Prequalification Accept informal audits and follow expert advice on how to upgrade GMP and dossier standards to meet WHO requirementsAccept informal audits and follow expert advice on how to upgrade GMP and dossier standards to meet WHO requirements Cooperate with expert external and internal of WHO such as on gap analysis and remediation planCooperate with expert external and internal of WHO such as on gap analysis and remediation plan Make financial investments for quality upgrade, if neededMake financial investments for quality upgrade, if needed

14. World Health Organization, Beijing China Project activities Informal Visits by experts with international experience to assess existing level of GMP compliance and product documentation with regard to anti-TB FDCs.Informal Visits by experts with international experience to assess existing level of GMP compliance and product documentation with regard to anti-TB FDCs. Deviations from international standards will be identified and, if necessary, plans to achieve full compliance will be developed (e.g. investment needs).Deviations from international standards will be identified and, if necessary, plans to achieve full compliance will be developed (e.g. investment needs). Trainings focusing on areas of need will be organized during repeated consultancies to manufacturers.Trainings focusing on areas of need will be organized during repeated consultancies to manufacturers. In addition to individual consultancies, guiding documents will be developed on areas of GMP, documentation of product quality and bioequivalence.In addition to individual consultancies, guiding documents will be developed on areas of GMP, documentation of product quality and bioequivalence.

15. World Health Organization, Beijing China Timeline WHO project duration: 18 months (Nov 2009 - May 2011)WHO project duration: 18 months (Nov 2009 - May 2011) Trainings for FDC manufacturers (GMP, Quality, BE) are planned for October 2010, open to limited number of other interested manufacturersTrainings for FDC manufacturers (GMP, Quality, BE) are planned for October 2010, open to limited number of other interested manufacturers End of April 2011: dissemination of GMP, dossier and BE guideline (English and Chinese version) expectedEnd of April 2011: dissemination of GMP, dossier and BE guideline (English and Chinese version) expected

16. World Health Organization, Beijing China Q&A Inclusion of API manufacturers in Gates Project? First focus of this project is on FPPs (due to project limits) However, specific support to a limited number of API manufacturers is planned Support would also aim to move them towards WHO prequalification. Preference: API manufacturers supplying APIs for production of FPPs which are planned to be submitted for WHO prequalification.

17. World Health Organization, Beijing China Q&A Which FDC formulations are relevant for the project? The project focuses on 2- and 4- drug combination FDCs with priority to WHO recommended formulations*. 3-drug combination FDCs are considered as back-up in the transition phase. *WHO recommended formulations: see http://www.who.int/medicines/publications/essentialmedicines/en and http://www.who.int/selection_medicines/list/en http://www.who.int/medicines/publications/essentialmedicines/en

18. World Health Organization, Beijing China Additional information Christina Foerg-Wimmer, PhD. Technical Officer Tel: (+86 10) 6532 7189 to 92 extension 81287 Fax: (86 10) 6532 2359 stc15.chn@wpro.who.int stc15.chn@wpro.who.int Huang Baobin, MD Programme Officer Tel: (+86 10) 6532 7189 to 92 extension 81213 Fax: (86 10) 6532 2359 huangb@wpro.who.int huangb@wpro.who.int WHO World Health Organization 401 Dongwai Diplomatic Office Building # 23 Donghzimenwai Dajie Chaoyang District Beijing 100600, China http://www.wpro.who.int/china

19. World Health Organization, Beijing China Thank you for your attention!