Improving the Safety of Medicines in the European Union: From Signals to Action.
Adverse Drug Reaction Reporting Systems
Drug Development
/ legislation & jurisprudence
Drug Labeling
/ legislation & jurisprudence
Drug-Related Side Effects and Adverse Reactions
/ epidemiology
European Union
Humans
Legislation, Drug
Pharmacovigilance
Risk Assessment
/ methods
Risk Management
/ methods
Journal
Clinical pharmacology and therapeutics
ISSN: 1532-6535
Titre abrégé: Clin Pharmacol Ther
Pays: United States
ID NLM: 0372741
Informations de publication
Date de publication:
03 2020
03 2020
Historique:
received:
25
06
2019
accepted:
13
10
2019
pubmed:
18
10
2019
medline:
29
10
2020
entrez:
18
10
2019
Statut:
ppublish
Résumé
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.
Identifiants
pubmed: 31621897
doi: 10.1002/cpt.1678
pmc: PMC7027976
doi:
Types de publication
Journal Article
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
521-529Informations de copyright
© 2019 The Authors. Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.
Références
Drug Saf. 2015 Jun;38(6):577-87
pubmed: 25899605
Nat Rev Drug Discov. 2014 May;13(5):395-7
pubmed: 24751815
Drug Saf. 2018 Jul;41(7):665-675
pubmed: 29520645
Drug Saf. 2016 Jun;39(6):469-90
pubmed: 26951233
Drug Saf. 2017 Oct;40(10):855-869
pubmed: 28735357
BMJ Open. 2018 Jan 23;8(1):e019759
pubmed: 29362275
Drug Saf. 2013 Aug;36(8):687-92
pubmed: 23754759
Drug Saf. 2010 Jun 1;33(6):475-87
pubmed: 20486730
Pharmacoepidemiol Drug Saf. 2018 Jan;27(1):38-45
pubmed: 29143393
PLoS Med. 2008 Mar 11;5(3):e67
pubmed: 18336067