An Overview of the Herbal Product Regulatory Classification in Asia and General Guidelines for Health Product Development

2021 ◽  
pp. 701-706
Author(s):  
Jacob Cheong
2020 ◽  
pp. 205-240
Author(s):  
Mirian Pateiro ◽  
Rubén Domínguez ◽  
Predrag Putnik ◽  
Danijela Bursać Kovačević ◽  
Francisco J. Barba ◽  
...  

2018 ◽  
Vol 2 ◽  
pp. 24 ◽  
Author(s):  
Robert F Terry ◽  
Gavin Yamey ◽  
Ryoko Miyazaki-Krause ◽  
Alexander Gunn ◽  
John C. Reeder

Background: the Portfolio-To-Impact (P2I) model is a novel financial model, developed to estimate minimum funding needs to accelerate health product development from late stage preclinical study to phase III clinical trials, and to visualize potential product launches over time (from 2017 to 2040). Methods: The assumptions on development costs at each phase were based on clinical trial costs from Parexel’s research and development (R&D) cost sourcebook. These were further refined and validated by interviews, with a wide variety of stakeholders from Product Development Partnerships, biopharmaceutical and diagnostic companies, and major funders of global health R&D. Results: the tool was used to create seven scenarios describing the impact, in terms of products developed, with different product portfolios of funding ranging from $1 million per annum through to $500 million per annum. These scenarios have been previously presented in a report setting out the potential for a new fund for research and development which would assist in accelerating product development for the diseases of poverty.  Conclusion:  this article describes the assumptions and methods used in developing the P2I modelling tool.  The model is published as open access accompanied with a user guide.  The design allows it to be adapted and used for other health R&D portfolio analysis as described in an accompanying publication focussing on the pipeline for neglected diseases in 2017. We aim to continually refine and improve the model and we ask users to provide us with their own inputs that can help us update key parameters and assumptions.  We hope to catalyse users to adapt the model in ways that can increase its value, accuracy, and applications.


Planta Medica ◽  
2009 ◽  
Vol 75 (04) ◽  
Author(s):  
EZ Wang ◽  
Y Jiang

2018 ◽  
Vol 2 ◽  
pp. 24 ◽  
Author(s):  
Robert F Terry ◽  
Gavin Yamey ◽  
Ryoko Miyazaki-Krause ◽  
Alexander Gunn ◽  
John C. Reeder

Background: The Portfolio-To-Impact (P2I) Model is a novel tool, developed to estimate minimum funding needs to accelerate health product development from late stage preclinical study to phase III clinical trials, and to visualize potential product launches over time. Methods: A mixed methods approach was used. Assumptions on development costs at each phase were based on clinical trial costs from Parexel’s R&D cost sourcebook. These were further refined and validated by interviews, with a wide variety of stakeholders from Product Development Partnerships, biopharmaceutical and diagnostic companies, and major funders of global health R&D. Results: the tool was used to create scenarios describing the impact, in terms of products developed, of different product portfolios with funding ranging from $1 million per annum through to $500 million per annum. These scenarios for a new global financing mechanism have been previously presented in a report setting out the potential for a new fund for research and development which would assist in accelerating product development for the diseases of poverty.  Conclusion: The P2I tool does enable a user to model different scenarios in terms of cost and number of health products launched when applied to a portfolio of health products.  The model is published as open access accompanied with a user guide.  The design allows it to be adapted and used for other health R&D portfolio analysis as described in an accompanying publication focussing on the pipeline for neglected diseases in 2017. We aim to continually refine and improve the model and we ask users to provide us with their own inputs that can help us update key parameters and assumptions.  We hope to catalyse users to adapt the model in ways that can increase its value, accuracy, and applications.


2005 ◽  
Vol 83 (4) ◽  
pp. 321-334 ◽  
Author(s):  
Yaw L Siow ◽  
Yuewen Gong ◽  
Kathy K.W Au-Yeung ◽  
Connie W.H Woo ◽  
Patrick C Choy ◽  
...  

Traditional Chinese medicine (TCM) has many beneficial effects and has been practiced for several thousand years. It is known to treat the cause of a disease rather than to alleviate its symptoms. Based on a belief that TCM is natural, safe, and of lower cost, consumers worldwide are spending more out-of-pocket money on this form of therapy. This increased spending, and reports of adverse reactions, has drawn the attention of many regulatory agencies. Scientists have called for more evidence-based and scientific research on the risks and benefits of TCM. In Canada, the Natural Health Product Regulations came into effect January 2004. TCM herbal product manufacturers will need to provide products of reputable quality to the market. Many will apply modern technology and good science to support their products. The issues facing producers, scientists, and consumers alike are quality control and assessment, standardization of bioactive components, mechanisms of actions, and integration of the evolved modern Chinese medicine into the healthcare system. Solid science, better regulation of the final product, and better education of consumers are necessary to extract the best of TCM to complement existing conventional medicine to deliver the best healthcare.Key words: bioactive components, chromatographic fingerprinting, integration, mechanisms, Natural Health Product (NHP) Regulations, standardization, traditional Chinese medicine.


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