Evidence map›Paper›PMID 28894633›Full record

ReviewJournal of intercultural ethnopharmacology

Establishment of Application Guidance for OTC non-Kampo Crude Drug Extract Products in Japan.

Layla Somekawa, Hikoichiro Maegawa, Shinsuke Tsukada, Takatoshi Nakamura

Abstract readReview
In one paragraph

Review in Journal of intercultural ethnopharmacology. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

  1. Review
  2. Pharmacological Activities forFoods (Basel, Switzerland) · 2021
    Review
  3. Review
  4. Review
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

4 authors.

Layla SomekawaOffice of OTC/Quasi-drugs, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Hikoichiro MaegawaOffice of Vaccines and Blood Products, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Shinsuke TsukadaOffice of New drugs IV, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Takatoshi NakamuraOffice of OTC/Quasi-drugs, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Currently, there are no standardized regulatory systems for herbal medicinal products worldwide. Communication and sharing of knowledge between different regulatory systems will lead to mutual understanding and might help identify topics which deserve further discussion in the establishment of common standards. Regulatory information on traditional herbal medicinal products in Japan is updated by the establishment of Application Guidance for over-the-counter non-Kampo Crude Drug Extract Products. We would like to report on updated regulatory information on the new Application Guidance. Methods for comparison of Crude Drug Extract formulation and standard decoction and criteria for application and the key points to consider for each criterion are indicated in the guidance. Establishment of the guidance contributes to improvements in public health. We hope that the regulatory information about traditional herbal medicinal products in Japan will be of contribution to tackling the challenging task of regulating traditional herbal products worldwide.

Indexed as

Pharmaceuticals and Medical Devices Agency (PMDA)regulationtraditional herbal medicine

Identifiers

PMID28894633
PMCPMC5580960

What OpenQuestion holds

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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.