WHO Projects Organized in
Cooperation with SFDA in
China
Christina Foerg-Wimmer, PhD
Pharmaceutical Advisor
WHO China Office
May 18, 2011 | Beijing, China
WHO Projects Organized in Cooperation with
SFDA in China
Current projects focusing on quality and safety of pharmaceutical
products, sponsored by
• Bill and Melinda Gates Foundation (BMGF)
– 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
(WHO TA over 18 months, WHO budget US$ 1.5 million, SFDA US$ 0.5 million)
• Global Fund to Fight HIV/AIDS, TB and Malaria (GFATM)
– To improve the quality of anti-TB, HIV/AIDS and malaria medicine
produced in China to ensure improved accessibility and patient
outcomes.
(Initial 3-year program of work approved including US$ ~ 4.2 million for WHO TA,
total consolidated HSS budget US$ ~25.5)
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BMGF 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)
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TB FDCs 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.
*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
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BMGF – Project activities
1. GMP: Support 4 manufacturers of FDC anti-TB drugs in
implementing WHO GMP standards, and in meeting requirements
for participating in WHO PQ program
2. Post-market surveillance: Provide technical support to quality
control testing labs for TB FDC drugs in China.
3. Pharmacopeia: Support the Chinese Pharmacopeia Committee
(CPhC) in revising or drafting monographs of TB FDC drugs and of
their respective APIs for inclusion in the Chinese Pharmacopeia.
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BMGF - GMP part
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,
strengthen their role on domestic market and increase export
opportunities
• implement new GMP standards
• move towards WHO prequalification. WHO prequalification functions as
a gate-keeping mechanism to enter international tenders and
procurement is growing
• better understand GMP and data requirements for FDCs which is of
benefit not only for FDC but all other drug production
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BMGF - GMP part
Manufacturers participating in the project commit themselves to:
• Produce or develop TB FDCs (in line with WHO recommended
formulations)
• 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
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GFATM complex project
Project overall objective
Reducing the morbidity and mortality from M/XDR-TB in China
HSS cross-cutting intervention:
Improving the quality of anti-TB, HIV/AIDS and malaria
medicine produced in China to ensure improved accessibility
and patient outcomes.
2010 – Signature of project
agreement
Resources planned for 3 years
with possible extension
until 2015 (total 5 years)
HIV
TB
HSS
HSS Cross Cutting
Interventions are
described under TB
part of proposal
Malaria
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GFATM HSS project components
Objective 1: GMP
– implement revised GMP standards,
– strengthen GMP inspection system,
– promote WHO Prequalification
Objective 2: Strengthen the national quality control system by
– prequalification of reference quality control laboratory,
– implementation of quality system in the network of official QCLs
– widening the scope of NIS field controls
Objective 3: Chinese Pharmacopoeia
– revision of existing or development of new pharmacopoeial
monographs for selected anti-HIV/AIDs, TB and malaria medicines
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GFATM – Strengthening of GMP standards in China
•
Support to 400 selected API and FPP manufacturers producing
HIV/AIDS, TB and Malaria medicines to
•
implement revised GMP standards and achieve international
acceptability and
• to pass WHO PQ
–
Indicator: 200 manufacturers of selected ARVs, TB and Malaria medicines
compliant with revised GMP
•
Training of GMP inspectors
•
Development and implementation of QMS for SFDA inspectorates
–
–
Indicator: Number of inspectors passed post training competency
evaluation (GMP and QMS for GMP) - 1816 trained, 80% pass
Indicator: 2 out of 32 inspectorates established QMS for GMP according to
international standards
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GFATM – Strengthening of GMP standards in China
Activities to strengthen GMP standards include:
• Extensive trainings by international experts (for GMP inspectors and
manufacturers)
• Seminars and workshops such as to resolve difficulties in implementation
of revised GMP and develop an implementation strategy
• Regional meetings such as on GMP implementation status, impact
assessment, WHO PQ
• Joint inspections to manufacturers by SFDA and international experts
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GFATM – Quality Control part
Building a reliable network of Quality Control labs in China
•
•
386 QC labs across China are included
Development of QMS for quality control laboratories
(NIFDC and network of QC labs)
–
•
Trainings of lab personnel on QMS and QC testing
–
•
•
•
Indicator: 6 QC labs implemented Quality Management Systems
according to international standards
Indicator: Number of QC lab staff trained and passed final competency
examination - 540, 90% pass
Prequalification of national reference quality control laboratory
(NIFDC)
Audits of QC labs and development of CAPA plans.
Strengthening of post-marketing surveillance by mobile testing units.
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GFATM – Pharmacopeia part
Revision of selected monographs in Chinese Pharmacopeia
•
Collection and evaluation of data from manufacturers on synthetic
methods and manufacturing processes
•
Harmonization of monographs with major Pharmacopeias (i.e.
PhEur, USP, BP, PhInt), reflecting ICH quality guidelines
•
Monographs of APIs and FPPs are included, focus on antiHIV/AIDS, malaria and TB medicines
– Indicator: 50 monographs reviewed in Chinese/International
pharmacopoeia and SFDA standards
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Industry situation
Current status of China’s pharmaceutical industry:
•~4700 manufacturers of APIs and FPPs
•Mainly small to medium scale manufacturers
•Number of international certifications and participation in
international tenders is low
•Consolidation of pharmaceutical
industry expected after implementation
of new Chinese GMP
India
France
9
9
8 6 3
South Africa
3
1
UK
11
Germany
11
Switzerland
USA
11
12
194
Canada
Spain
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Countries where prequalified medicines
are manufactured (July 2009)
Netherlands
China
Australia
Morocco
Pakistan
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WHO PQ in China (April 2011)
Therapeutic
area
INN
Formulation
Applicant
Manufacturing site
Packaging
Reference
HIV
Nevirapine
Tablets
Huahai US Inc.
Zhejiang Huahai Pharmaceutical Co.
Ltd, Zhejiang, P.R. China
HDPE bottle 60
USFDA2
MA
Amodiaquine
Film-coated
tablets
Guilin
Pharmaceutical
Co. Ltd
Guilin, Guangxi, China
PVC/Alu blisters 6;
Cardboard box 2 x 6
MA045
MA
Amodiaquine +
Artesunate
Tablets
Guilin
Pharmaceutical
Co. Ltd
Guilin, Guangxi, China
PVC/Alu blister 3x(4+4),
3+3, 6+6, 12+12
MA046
MA
Artemether +
Lumefantrine
Tablets
Novartis Pharma
Beijing, China;
Suffern, USA
Blister 6, 12, 18, 24
MA026
MA
Artesunate
Tablets
Guilin
Pharmaceutical
Co. Ltd
Guilin, Guangxi, China
Blister 12
MA044
MA
Artesunate
Powder for
Injection
Guilin
Pharmaceutical
Co., Ltd.
Guilin, Guangxi, P.R. China
Vial (glass) 60mg.
MA051
Challenges in availability of WHO prequalified essential medicines, such as paediatric
formulations, e.g. FDCs for HIV/AIDS and malaria, Artemisinin based FDCs for
malaria treatment, Second line treatment for TB, medicines for neglected diseases
(e.g. praziquantel for schistosomiasis)
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Links
• WHO website
http://apps.who.int/prequal/
WHO Prequalification website also provides information in Chinese
• MoH website:
GFATM R9 TB project kick-off meeting on 29 July, 2010.
http://www.moh.gov.cn/publicfiles/business/htmlfiles/mohjbyfkzj/s10
768/201007/48285.htm
• Gates project kick-off meeting on 1 April, 2009.
http://www.moh.gov.cn/publicfiles/business/htmlfiles/chenz/pldhd/20
0904/39806.htm
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Thank you for your attention!
Contact:
Christina Foerg-Wimmer, PhD
Pharmaceutical Advisor
WHO China Office
Tel: (+86 10) 6532 7189
FoergWimmerC@wpro.who.int
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