ArticleTherapeutic innovation & regulatory science2024
Draft Guideline for Industry to Manage Drug Shortages in Japan.
Article in Therapeutic innovation & regulatory science, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
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.
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.
Who cites it
4 citing papers in PubMed.
- Manufacturer-Perceived Development and Market-Entry Risks Associated with Discontinuation and Non-launch of Generic Medicines in Japan: A Cross-Sectional Survey of Marketing Authorization Holders.Pharmaceutical medicine · 2026Article
- Effect of Pharmacist-Led Educational Intervention on Switching to Generic Medicine Among Patients Using Brand-Name Medicines in Japan.Pharmacy (Basel, Switzerland) · 2026Article
- Japan essential medicine list and medicine supply issues: a cross-sectional study.Journal of pharmaceutical policy and practice · 2026Article
- Comprehensive Fertility Management After Pituitary Adenoma Surgery: Lessons from a Rural Japanese Case and Practical Review.Reports (MDPI) · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
Abstract
The increasing global drug shortage poses a substantial challenge to national healthcare systems and affects access to essential therapies. In Japan, this problem is exacerbated by a large-scale government campaign to switch from brand-name products to generic drugs and manufacturing/marketing authorization holders with poor development and manufacturing controls. Regulatory bodies, such as the U.S. Food and Drug Administration and the European Medicines Agency have developed guidelines aimed at ensuring continuous drug supply and mitigating manufacturing risks. However, Japan's efforts have primarily relied on voluntary industry guidelines, lacking the robust regulatory frameworks of other developed nations. Therefore, this study proposes a draft guideline for Japan's pharmaceutical industry to manage drug shortages effectively. The Japanese government needs to establish a framework system that will enable pharmaceutical companies to effectively maintain a stable supply based on the proposals developed in this study.
Indexed as
Identifiers
39048765What OpenQuestion holds
Registered trials
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.