ReviewPharmacoepidemiology and drug safety2020
Navigating stormy waters: 10 years of operation of the European Union Regulatory Network Incident Management Plan for Medicines for Human Use.
Review in Pharmacoepidemiology and drug safety, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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
1 citing paper in PubMed.
- Navigating stormy waters: 10 years of operation of the European Union Regulatory Network Incident Management Plan for Medicines for Human Use.Pharmacoepidemiology and drug safety · 2020Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe article provides an overview of the European Union Incident Management plan (EU-IMP) and reviews its first 10 years of operation. It outlines its scope, objectives, triggers, principles, and components.
methodsRecords were extracted from the European Pharmacovigilance Issues Tracking Tool and a separate tracking system for the period August 20, 2009 to August 19, 2019.
resultsDuring the 10 years of observation, 78 incidents were reviewed by the Incident Review Network and addressed through routine measures. Their number has varied throughout the years with a significant decrease after 2012. Incidents mainly covered safety (56%) and quality (34%) issues or a combination thereof (5%). The majority (70%) were notified by EU regulators and involved centrally and nationally authorized product in similar proportions. A referral was recommended as the assessment pathway for 47% of the issues while lines-to-take were the most frequent communication measure (the sole measure in 65% cases). Forty-six per cent of the issues resulted in a variation, whereas 22% resulted in maintenance of the marketing authorization.
conclusionThe EU-IMP is underpinned by a robust regulatory framework with defined processes and clear roles and responsibilities and offers a platform to coordinate actions and communication at EU level, rapidly pool expertise, minimize duplications, and address public health incidents.
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.