world health organization, beijing china who-gates project on tb improvement in china 30 march 2010...

World Health Organization, Beijing China

WHO-Gates projecton TB improvement in China

30 March 2010

Christina Foerg-Wimmer, PhD.WHO China Office


Gates project on TB control in China:

To substantially improve TB control in China.

Project background


Project background – Gates projects on TB control in China

China MoH – Gates Foundation TB project:China MoH – Gates Foundation TB project: Use of Innovative Tools and Delivery Approaches to Improve TB Use of Innovative Tools and Delivery Approaches to Improve TB control in China (5 years)control in China (5 years)

SFDA – Gates Foundation Subproject:SFDA – Gates Foundation Subproject: China anti-tuberculosis FDC drug quality assurance (2 years)China anti-tuberculosis FDC drug quality assurance (2 years)

WHO – Gates Foundation Project: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)


TB situation in China

China is the country with the world’s second largest TB China is the country with the world’s second largest TB epidemic, with 1.3 million new TB patients (all forms) every year. 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 most serious challenge facing the control of TB in China is the the emergence of a MDR-TB epidemicemergence of a MDR-TB epidemic..

To date, the standard treatment consists of first-line TB drug To date, the standard treatment consists of first-line TB drug treatment for all patients. treatment for all patients.

To prevent that patients with drug-resistant TB are receiving To prevent that patients with drug-resistant TB are receiving improper or inadequate treatment, fixed-dose combination (FDC) improper or inadequate treatment, fixed-dose combination (FDC) TB drugs in national TB control programs are being highly TB drugs in national TB control programs are being highly promoted.promoted.

FDC TB drugs are easier to handle and can help prevent the development of drug-resistant TB.


TB FDC demand

Global situation: Global situation:

Global needs for FDCs are not satisfied yet (not Global needs for FDCs are not satisfied yet (not many competitors existing), thus export many competitors existing), thus export opportunities for quality assured FDCs are high.opportunities for quality assured FDCs are high.

For international procurement, increased attention For international procurement, increased attention will be paid to the quality of products; international will be paid to the quality of products; international standards are expected.standards are expected.


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$.


TB FDC demand

Situation in China: Situation in China:

According to MoH/CDC guideline, the predicted According to MoH/CDC guideline, the predicted consumption of TB FDCs will increase consumption of TB FDCs will increase approximately 10 timesapproximately 10 times in the years 2010 -2013 in the years 2010 -2013 (MoH/CDC guideline). (MoH/CDC guideline).

Additionally, there will be also considerable demand Additionally, there will be also considerable demand from non-CDC users, once TB FDCs are available. from non-CDC users, once TB FDCs are available.


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


Project support

WHO – Gates Foundation Project: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)


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.


Project support

• The WHO and SFDA project focuses on support to FDCs The WHO and SFDA project focuses on support to FDCs manufacturers in their effort manufacturers in their effort – to implement to implement internationallyinternationally accepted GMP accepted GMP

standardsstandards and and– have available have available regulatoryregulatory dossiersdossiers, , whichwhich satisfy satisfy

WHO requirements.WHO requirements.

• This will help FDC manufacturers to be prepared for This will help FDC manufacturers to be prepared for implementation of revised GMP standards planned to be implementation of revised GMP standards planned to be soon binding in China.soon binding in China.

• Additionally, it will substantially increase chance to be Additionally, it will substantially increase chance to be successful when exporting FDCs outside China and/or successful when exporting FDCs outside China and/or when applying for WHO prequalification.when applying for WHO prequalification.


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


Project activities

Manfacturers participating in the project commit Manfacturers participating in the project commit themselves to:themselves to:

• Produce or develop TB FDCs (in line with WHO Produce or develop TB FDCs (in line with WHO recommended formulatios)recommended formulatios)

• Submit these medicines for WHO PrequalificationSubmit these medicines for WHO Prequalification• Accept informal audits and follow expert advice on Accept informal audits and follow expert advice on

how to upgrade GMP and dossier standards to meet how to upgrade GMP and dossier standards to meet WHO requirementsWHO requirements

• Cooperate with expert external and internal of WHO Cooperate with expert external and internal of WHO such as on gap analysis and remediation plansuch as on gap analysis and remediation plan

• Make financial investments for quality upgrade, if Make financial investments for quality upgrade, if neededneeded


Project activities

• Informal VisitsInformal Visits by experts with international experience to by experts with international experience to assess existing level of GMP compliance and product assess existing level of GMP compliance and product documentation with regard to anti-TB FDCs.documentation with regard to anti-TB FDCs.

• Deviations from international standards will be identified and, if Deviations from international standards will be identified and, if necessary, plans to achieve full compliance will be developed necessary, plans to achieve full compliance will be developed (e.g. investment needs).(e.g. investment needs).

• TrainingsTrainings focusing on areas of need will be organized during focusing on areas of need will be organized during repeated consultancies to manufacturers. repeated consultancies to manufacturers.

• In addition to individual consultancies, In addition to individual consultancies, guiding documentsguiding documents will be developed on areas of GMP, documentation of product will be developed on areas of GMP, documentation of product quality and bioequivalence. quality and bioequivalence.


Timeline

• WHO project duration: 18 months (Nov 2009 - May WHO project duration: 18 months (Nov 2009 - May 2011) 2011)

• Trainings for FDC manufacturers (GMP, Quality, BE) Trainings for FDC manufacturers (GMP, Quality, BE) are planned for October 2010, open to limited are planned for October 2010, open to limited number of other interested manufacturersnumber of other interested manufacturers

• End of April 2011: dissemination of GMP, dossier and End of April 2011: dissemination of GMP, dossier and BE guideline (English and Chinese version) expectedBE guideline (English and Chinese version) expected


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.


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


Additional information

Christina Foerg-Wimmer, PhD.

Technical Officer

Tel: (+86 10) 6532 7189 to 92 extension 81287Fax: (86 10) 6532 2359

[email protected]

Huang Baobin, MDProgramme Officer

Tel: (+86 10) 6532 7189 to 92 extension 81213Fax: (86 10) 6532 2359

[email protected]

WHO World Health Organization401 Dongwai Diplomatic Office Building# 23 Donghzimenwai DajieChaoyang DistrictBeijing 100600, China

http://www.wpro.who.int/china


Thank you for your attention!

world health organization, beijing china who-gates project on tb improvement in china 30 march 2010...

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