ReviewClinical pharmacology and therapeutics2020
Improving the Safety of Medicines in the European Union: From Signals to Action.
Review in Clinical pharmacology and therapeutics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 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
18 citing papers in PubMed.
- Cutaneous melanoma and JAK inhibitors: a disproportionality analysis in EudraVigilance.European journal of clinical pharmacology · 2026Article
- Article
- VigiBase: Resource Profile Update with a Summary of Global Patterns and Trends in Adverse Event Reports for Medicines and Vaccines.Drug safety · 2026Review
- Ecopharmacovigilance and pharmacovigilance: an analysis of environment-related reporting in VigiBase.Environmental science and pollution research international · 2026Article
- Resistance, Ineffectiveness, and Off-Label Use Related to Cephalosporins from the Reserve Group-A Pharmacovigilance Signal Detection Study on EudraVigilance Database.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Therapeutic Potential of Natural Xanthones Against Prostate Adenocarcinoma: A Comprehensive Review of Research Trends During the Last Ten Years (2014-2024).Pharmaceuticals (Basel, Switzerland) · 2025Review
- Review
- Discrepancies in regulations in post-marketing safety surveillance of drug-device combination products in the EU and US: a review.Frontiers in drug safety and regulation · 2025Review
- The STAR Compass to Guide Future Pharmacovigilance Based on a 10-Year Review of the Strengthened EU System.Drug safety · 2024Review
- Direct oral anticoagulants vs. vitamin K antagonists in patients with antiphospholipid syndrome: a systematic review and meta-analysis.Annals of medicine and surgery (2012) · 2023Article
- Characteristics of drug safety alerts issued by the Spanish Medicines Agency.Frontiers in pharmacology · 2023Article
- Vaccine Vigilance System: Considerations on the Effectiveness of Vigilance Data Use in COVID-19 Vaccination.Vaccines · 2022Article
- The Impact of Mandatory Reporting of Non-Serious Safety Reports to EudraVigilance on the Detection of Adverse Reactions.Drug safety · 2022Article
- Drug Interactions for Patients with Respiratory Diseases Receiving COVID-19 Emerged Treatments.International journal of environmental research and public health · 2021Review
- Identifiability of Biologicals: An Analysis Using EudraVigilance, the European Union's Database of Reports of Suspected Adverse Drug Reactions.Clinical pharmacology and therapeutics · 2021Article
- Unexpected beneficial effects of drugs: an analysis of cases in the Dutch spontaneous reporting system.European journal of clinical pharmacology · 2021Article
- Article
- Pharmacovigilance 2030: Invited Commentary for the January 2020 "Futures" Edition of Clinical Pharmacology and Therapeutics.Clinical pharmacology and therapeutics · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Pharmacovigilance and risk minimization must be planned during drug development and forms a critical part of the regulator's decision on whether a medicinal product can be authorized. Pharmacovigilance systems should ensure proactive monitoring of all authorized medicines throughout their lifecycle in clinical use. Signal detection and management are core activities in pharmacovigilance, rapidly delivering new information on the safety of medicines in real-world use which helps to fill knowledge gaps. The first 6 years of the European Union (EU) signal management system resulted in 453 recommendations issued by the Pharmacovigilance Risk Assessment Committee (PRAC), of which more than half were for drug labeling changes. The EU pharmacovigilance network has demonstrated its ability to detect and evaluate new drug safety signals. This has resulted in new warnings to guide the safe and effective use of medicines in Europe.
Indexed as
Identifiers
What 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.