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The regulation of off-label uses in the EU, EU Member States, and UK
Published in Andrea Parziale, The Law of Off-label Uses of Medicines, 2023
Conversely, for medicines with a domestic MA, MAHs must inform national authorities (Art. 23(2), paragraph 2, Directive 2001/83). National and supranational databases, such as Eudravigilance, collect data (Arts. 107(3) and 107a(4), Directive 2001/83). In turn, competent authorities can suspend, withdraw, or modify an authorisation if data shows, for example, that a product’s risk-benefit ratio is not favourable anymore (Arts. 14a, 20(4), 28(4), paragraph 2, Regulation 726/2004). If urgent action is needed to protect public health, the Member States and the European Commission may suspend the MA and prohibit the use of the medicinal product in question until a definitive decision is made (Art. 31(3)(4), Directive 2001/83). In the context of pharmacovigilance activities, MAHs can perform post-authorisation safety studies (PASS) voluntarily. The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) can also impose PASS as a specific obligation for an MA granted under exceptional circumstances (e.g., if a conditional MA is released).25 PASSs, also known as phase IV studies, may be either clinical trials or observational studies.26
Emerging Topics
Published in Demissie Alemayehu, Birol Emir, Michael Gaffney, Interface between Regulation and Statistics in Drug Development, 2020
Demissie Alemayehu, Birol Emir, Michael Gaffney
Finally, signal detection is an important framework for identification of a risk for developing a drug adverse event after being exposed to it. vigiRank is a predictive model for emerging safety signals using the VigiBase (Caster et al. 2017). Ordinarily the disproportionality analysis is based on assessing disproportionality in pharmacovigilance data by observed-expected ratios (Zink et al. 2013). Caster et al. (2017) showed that vigiRank has outperform disproportionality analysis in real-world pharmacovigilance signal detection. Similarly, the European Medicines Agency developed a predictive signal-detection algorithm and applied to the EudraVigilance database that showed encouraging results (Pinheiro et al. 2018).
Pharmacoepidemiology, public health and pharmacy
Published in Christine Bond, Ann Lewis, Using Medicines Information, 2018
The continuous, postmarketing monitoring of the safe use of medicinal products is a key area for pharmacovigilance and is important to the protection of public health. Within the European Economic Area (EEA), legislation is in place to ensure that national competent authorities, marketing authorisation holders, applicants and sponsors of clinical trials collect, collate and exchange data on adverse drug reactions. This is facilitated by EudraVigilance, the European data-processing network and management system that was launched in December 2001. From May 2004 the sponsors of all clinical trials in the EEA must ensure all relevant information about suspected unexpected serious adverse reactions (SUSARs) are reported and all SUSARs sent electronically to the EudraVigilance clinical trials module.1
Comparative assessment of myocarditis and pericarditis reporting rates related to mRNA COVID-19 vaccines in Europe and the United States
Published in Expert Review of Vaccines, 2022
Sophia Hatziantoniou, Cleo Anastassopoulou, George Lazaros, Konstantinos Vasileiou, Costas Tsioufis, Athanasios Tsakris
EudraVigilance is the system of the European Medicines Agency (EMA) for monitoring and analyzing suspected adverse reactions to medicines and vaccines reported from the EEA that includes 27 EU countries (Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, and Sweden) and also Iceland, Liechtenstein, and Norway [4]. VAERS, an early warning system comanaged by the Food and Drug Administration (FDA) and the US Centers for Disease Control and Prevention (CDC), records and analyzes possible adverse events postvaccination in the US [5]. Both EudraVigilance and VAERS are passive reporting systems where healthcare professionals, patients, and vaccine manufacturers can report adverse events. As such, both systems are subject to misreporting biases. Nonetheless, internal evaluation of reported adverse events, including detection and merging of duplicated cases, minimizes potential errors [4,5,10].
Pharmacovigilance of anti-cancer medicines: opportunities and challenges
Published in Expert Opinion on Drug Safety, 2020
Diana Crestan, Marta Paulina Trojniak, Sara Francescon, Giulia Fornasier, Paolo Baldo
In the European Union (EU), pharmacovigilance legislation aims to protect public health through: (1) the collection of high-quality data on drugs and their safety; (2) the rapid and robust assessment of issues related to drug safety; and (3) the encouragement of patients to report ADRs and to participate in drug safety activities, thereby facilitating the identification of new signals of risk for patients taking drugs [7]. An early step in the development of European pharmacovigilance was the 1968 implementation of the Programme for International Drug Monitoring [1]. 1992 saw the founding of the European Society of Pharmacovigilance, now called the International Society of Pharmacovigilance [8]. The European Medicines Agency (EMA) was established in 1995. EudraVigilance, a system for managing information about suspected ADRs to medicines authorized in the European economic area, was created in 2001 [9].
New safety signals assessed by the Pharmacovigilance Risk Assessment Committee at EU level in 2014–2017
Published in Expert Review of Clinical Pharmacology, 2018
Andrea Farcaş, Andreea Măhălean, Noémi Beátrix Bulik, Daniel Leucuta, Cristina Mogoșan
Almost half of the signals were detected by the EMA in the time frame evaluated. The efforts in signals management within the EU network are split between the EMA and the MS within a work-sharing process. For centrally authorized medicinal products, the EMA is responsible for EudraVigilance safety reports monitoring for signal detection. Half of the products in the time frame evaluated were centrally authorized – this explains why almost half of the signals were detected by the EMA. Lead MS are appointed to monitor data in EudraVigilance, to validate and confirm signals on behalf of the other MS, for active substances contained in medicinal products authorized nationally in more than one MS. Only validated signals by the EMA or MS are entered in the European Pharmacovigilance Issues Tracking Tool and will be brought to PRAC attention for further evaluation and recommendation for action. Therefore, only confirmed signals were evaluated.