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Field Identification of Matricaria chamomilla using a Portable qPCR System
Published on: October 10, 2020
[Regulatory sciences in herbal medicines and dietary supplements]
Kiichiro Tsutani1, Hiroki Takuma
1Department of Drug Policy and Management, Graduate School of Pharmaceutical Sciences, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan. tsutani-tky@umin.ac.jp
Summary
Regulatory science for herbal medicines and dietary supplements needs global development. Harmonizing current projects is recommended for better risk management and standardization, while respecting local contexts.
Area of Science:
- Regulatory science
- Traditional medicine
- Herbal products
Context:
- Regulatory science emerged in Japan in the late 1980s for pharmaceuticals.
- It is underdeveloped for herbal medicines and dietary supplements, leading to neglected risk assessment.
- Global concern over herbal product safety necessitates a worldwide regulatory system.
Purpose:
- To review current projects in regulatory science for herbal medicines and dietary supplements.
- To highlight the need for a coordinated global approach to regulation in this area.
Summary:
- Introduces projects like Herbal ATC (HATC) classification, WHO International Standardization of Terminology (IST), Forum for Harmonization of Herbal Medicines (FHH), CONSORT extension for herbal medicines, ICH M5, and ISO nomenclature activities.
- Identifies a lack of coordination among these harmonization initiatives.
- Recommends harmonizing and standardizing regulatory science for herbal medicines and dietary supplements, with attention to local variations.
Impact:
- Aims to improve risk perception, assessment, and management for herbal medicines and dietary supplements.
- Promotes global harmonization of regulatory standards.
- Encourages consideration of unique local situations in regulatory frameworks.
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