Evidence map›Paper›PMID 42029820›Full record

ArticleTherapeutic innovation & regulatory science2026

Present and Future Post-marketing Drug Safety Assessment in Japan: A PMDA Perspective.

Takashi Waki, Shinya Watanabe, Takashi Ando, Kazuhiro Kajiyama, Koichi Fukuda, Eiko Iwasa, Yukari Iwasaki, Masao Iwagami, Taihei Tanaka, Daisuke Maeda and 1 more

Abstract read
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In one paragraph

Article in Therapeutic innovation & regulatory science, 2026. 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

11 authors.

Takashi WakiOffice of Pharmacovigilance I, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Shinya WatanabeOffice of Pharmacovigilance I, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Takashi AndoOffice of Pharmacovigilance I, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Kazuhiro KajiyamaOffice of Pharmacovigilance I, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Koichi FukudaOffice of Pharmacovigilance I, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Eiko IwasaOffice of Pharmacovigilance I, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Yukari IwasakiOffice of Pharmacovigilance I, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Masao IwagamiOffice of Pharmacovigilance I, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Taihei TanakaOffice of Pharmacovigilance I, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Daisuke MaedaOffice of Pharmacovigilance II, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Yoshiaki UyamaCenter for Regulatory Science, Pharmaceuticals and Medical Devices Agency, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo, 100-0013, Japan. uyama-yoshiaki@pmda.go.jp.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

For pharmacovigilance, the Pharmaceuticals and Medical Devices Agency in Japan has utilized real world data (RWD) from multiple sources, including individual case safety reports, and medical information databases that capture routinely collected data from clinical practice. These RWD have their own characteristics with advantages and disadvantages. In this commentary, we describe current and future direction of post-marketing drug safety assessment in Japan.

Indexed as

Drug-Related Side Effects and Adverse ReactionsPharmacovigilanceProduct Surveillance, PostmarketingAdverse Drug Reaction Reporting SystemsHumansJapanArtificial intelligenceDrug safetyIndividual case safety reportsNew methods and technologyPharmacoepidemiologyPharmacovigilanceReal-world dataRegulatory decision

Identifiers

PMID42029820
PMCPMC13354710

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Registered trials

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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.