WHO-Gates project on TB improvement in China

1. WHO-Gates projecton TB improvement in China 30 March 2010 Christina Foerg-Wimmer, PhD. WHO China Office

2. Project background Gates project on TB control in China: To substantially improve TB controlin China.

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

9. 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. WHO Project activities • Objectives: • 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: 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: Provide technical support to quality control testing lab for anti-TB medicines produced in China.

11. The WHO and SFDA project focuses on support to FDCs manufacturers in their effort to implement internationallyaccepted GMP standards and have available regulatorydossiers, whichsatisfy WHO requirements. 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. Project support

12. 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 Project support

13. Manfacturers participating in the project commit themselves to: Produce or develop TB FDCs (in line with WHO recommended formulatios) Submit these medicines for WHO Prequalification Accept 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 plan Make financial investments for quality upgrade, if needed Project activities

14. 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). 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. Project activities

15. 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 manufacturers End of April 2011: dissemination of GMP, dossier and BE guideline (English and Chinese version) expected Timeline

16. 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. 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

18. Additional information • Christina Foerg-Wimmer, PhD. • Technical Officer • Tel: (+86 10) 6532 7189 to 92 • extension 81287 • Fax: (86 10) 6532 2359stc15.chn@wpro.who.int • Huang Baobin, MD • Programme Officer • Tel: (+86 10) 6532 7189 to 92 • extension 81213 • Fax: (86 10) 6532 2359huangb@wpro.who.int WHO World Health Organization401 Dongwai Diplomatic Office Building# 23 Donghzimenwai DajieChaoyang DistrictBeijing 100600, China http://www.wpro.who.int/china

19. Thank you for your attention!