ReviewEvidence-based complementary and alternative medicine : eCAM2021
Advancing the Regulation of Traditional and Complementary Medicine Products: A Comparison of Five Regulatory Systems on Traditional Medicines with a Long History of Use.
Review in Evidence-based complementary and alternative medicine : eCAM, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
15 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Second Asian Consensus Report on Functional Dyspepsia (2025): Updated Recommendations.Journal of gastroenterology and hepatology · 2026Pooled it
- Article
- International collaborative research and development (R&D) on traditional medicine and its contextual factors: a cross-sectional analysis from 1996 to 2022.Journal of global health · 2026Article
- Natural Bioactive Compounds Targeting FABP4 in Adipogenesis and Obesity: Evidence from In Vitro and In Vivo Studies.International journal of molecular sciences · 2026Review
- A Scoping Review of Published Literature on the Contributions of the Natural Health Products (NHPs) Industry to Pharmacovigilance for NHPs.Drug safety · 2026Article
- Regulatory and HTA framework for herbal medicines in Indonesia.Journal of pharmaceutical policy and practice · 2026Review
- The Role of Traditional Chinese Medicine in COVID-19 Treatment: Integrating Ancient Wisdom with Modern Medicine.Current medicinal chemistry · 2026Review
- WHO global research priorities for traditional, complementary, and integrative (TCI) medicine: an international consensus and comparisons with LLMs.Journal of global health · 2025Article
- Ex Vivo Traceability Platform for Phospholipoproteomic Formulations: Functional Evidence Without Clinical Exposure.Biomedicines · 2025Article
- Strengthening the traditional medicine regulation, education and practice in Nigeria.African health sciences · 2024Review
- Technology Readiness Level Roadmap for Developing Innovative Herbal Medicinal Products.Pharmaceuticals (Basel, Switzerland) · 2024Article
- A model of purchase intention of complementary and alternative medicines: the role of social media influencers' endorsements.BMC complementary medicine and therapies · 2023Article
- Have safety and efficacy assessments of bioactives come of age?Molecular aspects of medicine · 2023Review
- Article
- Navigating the regulatory landscape of herbal medicines: A global comparison of India, China, Europe, the United States and Japan.Journal of Ayurveda and integrative medicineReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAn appropriate regulatory system to ensure and promote the quality, safety, and efficacy of the products of traditional medicine (TM) and complementary medicine (CM) is critical to not only public health but also economic growth. The regulatory approach and evaluation standards for TM/CM products featured with a long history of use are yet to be developed. This study aims to investigate and compare the existing regulatory approaches for TM/CM products with a long history of use.
methodA mixed approach of documentary analysis involving official and legal documents from official websites, as well as a scoping review of scholarly work in scientific databases about regulatory systems of TM/CM products in China, Hong Kong, Taiwan, Japan, and Korea, was employed in this study and used for comparison.
resultsFor registration purposes, all five regulatory systems recognized the history of use as part of the totality of evidence when evaluating the safety and efficacy of TM/CM products with a long history of use. Generally, the list of classic formulas is predefined and bound to the formulas recommended in the prescribed list of ancient medical textbooks. Expedited pathways are usually in place and scientific data of nonclinical and clinical studies may be exempted. At the same time, additional restrictions with the scope of products constitute a comprehensive approach in the regulation. Quality assurance and postmarketing safety surveillance were found to be the major focus across the regulatory schemes investigated in this study.
conclusionThe regulatory systems investigated in this study allow less stringent registration requirements for TM/CM products featured with a long history of use, assuming safety and efficacy to be plausible based on historic use. Considering the safety and efficacy of these products, regulatory standards should emphasize the technical requirements for quality control and postmarket surveillance.
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.