Transcript Briefing on Gates and GFATM projects on medicines regulations

WHO-Gates project
on TB improvement in China
30 March 2010
Christina Foerg-Wimmer, PhD.
WHO China Office
World Health Organization, Beijing China
Project background
Gates project on TB control in China:
To substantially improve TB control in China.
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)
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.
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.
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$).
The global market for second-line anti-TB drugs will reach 120
million US$.
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.
World Health Organization, Beijing China
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
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)
World Health Organization, Beijing China
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.
World Health Organization, Beijing China
Project support
• The 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.
•
Additionally, it will substantially increase chance to be successful
when exporting FDCs outside China and/or when applying for WHO
prequalification.
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
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)
• 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
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.
• 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.
World Health Organization, Beijing China
Timeline
• 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
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.
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
World Health Organization, Beijing China
Additional information
Christina Foerg-Wimmer, PhD.
Technical Officer
Huang Baobin, MD
Programme Officer
WHO World Health Organization
401 Dongwai Diplomatic Office Building
# 23 Donghzimenwai Dajie
Chaoyang District
Beijing 100600, China
Tel: (+86 10) 6532 7189 to 92
extension 81287
Fax: (86 10) 6532 2359
[email protected]
Tel: (+86 10) 6532 7189 to 92
extension 81213
Fax: (86 10) 6532 2359
[email protected]
http://www.wpro.who.int/china
World Health Organization, Beijing China
Thank you for your attention!
World Health Organization, Beijing China