Evidence map›Paper›PMID 42190612›Full record

ReviewJournal of Ayurveda and integrative medicine

Navigating the regulatory landscape of herbal medicines: A global comparison of India, China, Europe, the United States and Japan.

Anil Tukaram Pawar, S B Chandrasekar, M P Venkatesh

Abstract readReview
In one paragraph

Review in Journal of Ayurveda and integrative medicine. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors.

Anil Tukaram PawarCentre of Excellence in Regulatory Sciences, Department of Pharmaceutics, Pharmaceutical Regulatory Affairs Group, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Mysuru, 570015, Karnataka, India.
S B ChandrasekarDepartment of Drugs Control, Drug Testing Laboratory, Government of Karnataka, Palace Road, Bangalore, 560001, Karnataka, India.
M P VenkateshCentre of Excellence in Regulatory Sciences, Department of Pharmaceutics, Pharmaceutical Regulatory Affairs Group, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Mysuru, 570015, Karnataka, India; Faculty of Pharmaceutical Sciences, USCI University, Kaula Lampur, Malaysia. Electronic address: venkateshmpv@jssuni.edu.in.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The use of herbal medicines is expanding rapidly worldwide, but regional regulatory systems vary greatly, leading to variations in quality, safety and efficacy. Varying legal frameworks, insufficient quality control and gaps in post-market surveillance create challenges in ensuring the reliability of herbal products. This study aims to analyze and compare the regulations that oversee herbal medicines in five major regions: India, China, Europe, the United States and Japan, highlighting key challenges and proposing recommendations for improving global regulatory alignment. Data were collected from official regulatory websites and scholarly articles. Additionally, the study tracked the progress of related regulations, advancements in scientific research, and the evolving infrastructure in the respective five geographical areas. The study examined regulatory components, including licensing requirements, pre-market validation, quality control and post-market surveillance across these five regions. Regulatory approaches vary significantly: Europe and Japan emphasize pre-market validation and scientific evidence, while the U.S. relies more on post-market monitoring. India and China integrate traditional practices with modern regulatory frameworks. These differences pose challenges for ensuring consistent safety and quality standards globally. Potential solutions involve adopting Good Manufacturing Practices (GMPs), harmonizing pharmacopoeial standards and leveraging emerging technologies such as artificial intelligence for quality assurance and supply chain transparency. Achieving global regulatory harmonization is crucial for ensuring the safety and efficacy of herbal medicines while preserving traditional knowledge. Strengthening international collaboration, enforcing standardized quality measures, and integrating scientific validation into traditional systems can enhance consumer confidence and facilitate international trade in herbal medicines.

Indexed as

Herbal medicineRegulatory authoritiesRegulatory requirements

Identifiers

PMID42190612
PMCPMC13226798

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.