Evidence map›Paper›PMID 33048367›Full record

ArticleClinical pharmacology and therapeutics2021

Evolving Landscape of New Drug Approval in Japan and Lags from International Birth Dates: Retrospective Regulatory Analysis.

Mototsugu Tanaka, Mayumi Idei, Hiroshi Sakaguchi, Ryosuke Kato, Daisuke Sato, Kenji Sawanobori, Shuichi Kawarasaki, Toshiyuki Hata, Asako Yoshizaki, Miki Nakamura and 1 more

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Article in Clinical pharmacology and therapeutics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers.

0numbers the graph read from it
0cells of the map it votes in
26citing 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

26 citing papers in PubMed.

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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.

Mototsugu TanakaOffice of New Drug 1, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Mayumi IdeiOffice of New Drug 1, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Hiroshi SakaguchiOffice of New Drug 1, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Ryosuke KatoOffice of New Drug 1, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Daisuke SatoOffice of New Drug 1, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Kenji SawanoboriOffice of New Drug 1, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Shuichi KawarasakiOffice of New Drug 2, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Toshiyuki HataOffice of New Drug 3, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Asako YoshizakiOffice of New Drug 4, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Miki NakamuraOffice of New Drug 5, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Mutsuhiro IkumaOffice of New Drug 1, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The Pharmaceuticals and Medical Devices Agency (PMDA) has approved hundreds of new drugs in recent years. We retrospectively analyzed the new drugs approved in Japan from 2008 to 2019, and identify the first-in-world approvals and clarify the current drug lag. The new drug and the drug lag were defined as a drug with a new active substance and a difference between the approval date in Japan and the international birth date, respectively. Among 400 new drugs approved in Japan during the last 12 years, 80 (20.0%) were first approved in Japan, and 320 were outside Japan (the United States: 202, 50.5%; Europe: 82, 20.5%; other regions: 36, 9.0%). Of these, 45 new drugs have not yet been approved outside Japan, and the remaining 355 have been globally approved in Japan and overseas. The number of new drug approvals were the largest in oncology followed by metabolic/endocrine and infectious diseases. The median drug lags (year) among all 400 new drugs and 355 new drugs with global approvals were 4.3 and 4.7 in the first tertile (2008-2011), 1.5 and 2.6 in the second tertile (2012-2015), and reduced to 1.3 and 2.2 in the third tertile (2016-2019), respectively. Substantial drug lag remains in neurology, psychiatry, and therapeutic areas where the number of new drug approvals was relatively small. Collectively, one-fifth of the new drugs approved in Japan are first-in-world approvals. Drug lag has been greatly decreased, although it still exists.

Indexed as

Drug ApprovalDrug IndustryEuropeHumansJapanRetrospective StudiesTime FactorsUnited States

Identifiers

PMID33048367
PMCPMC8246743

What Socratic holds

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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 Socratic graph.