Evidence map›Paper›PMID 40625428›Full record

ArticleJournal of pharmaceutical policy and practice2025

Current and future perspective of registry utilisation for regulatory settings in Japan: pharmaceuticals, medical devices, and regenerative medicine products.

Chieko Ishiguro, Yasutomo Teshima, Harumasa Nakamura

Abstract read
In one paragraph

Article in Journal of pharmaceutical policy and practice, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

3 authors.

Chieko IshiguroLaboratory of Clinical Epidemiology, Department of Data Science, Center for Clinical Sciences, Japan Institute for Health Security, Tokyo, Japan.
Yasutomo TeshimaPharmacovigilance and Post Marketing Surveillance, Aculys Pharma Inc., Tokyo, Japan.
Harumasa NakamuraDepartment of Clinical Research Support, Clinical Research & Education Promotion Division, National Center Hospital, National Center of Neurology and Psychiatry, Tokyo, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Considerable attention has been paid to the utilisation of real-world data throughout the lifecycle of pharmaceuticals, medical devices, and regenerative products. In Japan, regulatory initiatives have been implemented to promote the utilisation of real-world data and evidence for regulatory decision-making, especially focusing on the use of disease registries. In this brief article, we outline regulatory initiatives, summarise the current status of registry utilisation in Japanese regulatory settings, and offer points to consider and perspectives on registry utilisation for stakeholder collaboration.

Indexed as

JapanReal-world datareal-world evidenceregistryregulatory

Identifiers

PMID40625428
PMCPMC12231278

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.