The aim of WP7 is to establish a collaborative network towards formulating an easy-to-follow statement on the various regulatory frameworks, emphasising the synergies and highlighting the differences with the aim of helping to establish a universal harmonised regulatory framework for botanicals.
Main activities of WP7:
- Discuss the problems and solutions in developing Chinese materia medica as proprietary Chinese herbal medicines that meet the market-entry standard
- Emphasise on application of emerging functional genomics technology in this specific area
- Interface with regulatory agencies in the European Union (EMEA = European Medicines Agency) and China (SFDA = State Food and Drug Administration)
- Undertake analysis of the Botanical Guidelines in the United States (FDA = Food and Drug Administration) and equivalent guidelines in Australia (TGA = Therapeutic Goods Administration) and Canada (NHPD = Natural Health Products Directorate)
- Propose a universal harmonized registration strategy
Interaction with other WPs:
- Coordinate discussions on genomics technologies that might be applicable to assessing and elucidating the mechanisms-of-action of applicable CHM entities
- Identify useful CHM composite formulae that can be screened by such technology for prevention or treatment of disease conditions that limitations are shown in modern medical practice
- Coordinate with other WPs on the use of technology & methodology as needed by the regulatory requirements: Quality Control (WP1), Extraction and Component Analysis (WP2), Safety Assessment (WP3), In Vitro Screening (WP4), In Vivo Studies (WP5) of Chinese Herbal Medicines
- Coordinate with Clinical Studies (WP6) in the development of biomarkers and patients reported outcomes.
Interaction with external bodies:
We have established contacts with representatives from EMEA, SFDA and FDA and will be consulting with them at regular intervals. In addition, we are developing collaborative programmes with research institutes and pharmaceutical companies in China.
Potential WP impact:
By consulting with key regulatory agents and members of other work packages within GP-TCM, we aim to propose a universal harmonized registration strategy for guiding product development of Chinese herbal medicines.
WP7 Members:
Beneficiary members
Prof. Kelvin Chan (WP7 Co-Coordinator, University of Sydney & University of Western Sydney, Australia)
Dr. Tai-Ping Fan (WP7 Co-Coordinator, University of Cambridge, UK)
Dr Anu Aaspõllu (Asper Biotech, Estonia)
Dr. Qihe Xu (King’s College London, UK)
Prof. Chenghai Liu (Shanghai University of Traditional Chinese Medicine, China)
Prof. Peter Hylands (King’s College London, UK)
Prof. Werner Knöss (Federal Institute for Drugs and Medical Devices, Germany)
Non-beneficiary members
Dr. Abraham Chan (PuraPharm, China)
Dr. Daryl Rees (Salupont Consulting, UK)
Dr. Shongming Zhong (Honorary Assistant Coordinator, retired from Phynova, UK)
Dr. Svetlana Ignatova (Brunel University, UK)
Mr. Alan Hoi Lun Koo (River Cam International, China)
Mr. Bobby Deal (Global Regulatory Services, UK)
Mr. Marshall Ma (Link China Pharma Solutions, UK)
Mr. Stephen Leung (Pfizer Corporation Hong Kong, China)
Mrs. Greer Deal (WP7 Deputy Coordinator, Global Regulatory Services)
Ms. Lina Svedlund (Tasly Institute, China)
Ms. Nadine Su (Link China Pharma Solutions, UK)
Prof. David Briggs (University of Western Sydney, Australia)
Prof. Ian Sutherland (Brunel University, UK)
Prof. Liping Zhao (Shanghai Jiaotong University, China)
Prof. Olavi Pelkonen (Department of Pharmacology, University of Oulu, Finland)
Prof. William Jia (University of British Columbia, Canada)
Prof. Zuguang Ye (China Academy of Chinese Medical Science, China)
Advisory Board members:
Academician Prof. Xinsheng Yao (Jinan University, China)
Prof. Gerhard Franz (University of Regensburg, Germany)
Prof. Vivian Wong (Hospital Authority, Hong Kong, China)
Prof. Yi-Tao Wang (University of Macau, China)
WP7 Contact:
Dr. Tai-Ping Fan
WP7 Co-Coordinator
Angiogenesis & Chinese Medicine Laboratory
Department of Pharmacology
University of Cambridge
Cambridge
CB2 1PD
United Kingdom
Tel: +44 1223 334 015
Fax: +44 1223 334 100
E-mail: [email protected]
