Risk Minimization Activities of Centrally Authorized Products in the EU

Zomerdijk, Inge M.; Sayed‐Tabatabaei, Fakhredin A.; Trifirò, Gianluca; Blackburn, Stella; Sturkenboom, Miriam; Straus, Sabine M. J. M.

doi:10.2165/11594560-000000000-00000

Cited by 32 publications

(29 citation statements)

References 20 publications

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“…This guidance was implemented in EU regulation in 2005 in the form of the EU risk management plan (EU‐RMP), which is a mandatory template document for the authorization dossier of innovative drugs licensed in the EU . The EU‐RMP describes the important risks and areas of missing information, the activities intended to further characterize the safety profile, and the measures to minimize the risks . The EU‐RMP is updated throughout the product life cycle as studies are completed or new information becomes available that may change the benefit‐risk balance .…”

Section: Pms System For Medicinal Products and Medical Devices In The Eumentioning

confidence: 99%

“…[10][11][12] The EU-RMP describes the important risks and areas of missing information, the activities intended to further characterize the safety profile, and the measures to minimize the risks. 13,14 The EU-RMP is updated throughout the product life cycle as studies are completed or new information becomes available that may change the benefit-risk balance. 15 Significant variation exists in the requirements and execution of postauthorization safety studies…”

Section: Medicinal Productsmentioning

confidence: 99%

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EU postmarket surveillance plans for medical devices

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Francisca

Verhamme

et al. 2019

Pharmacoepidemiology and Drug

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Purpose Recent public health safety issues involving medical devices have led to a growing demand to improve the current passive‐reactive postmarket surveillance (PMS) system. Various European Union (EU) national competent authorities have started to focus on strengthening the postmarket risk evaluation. As a consequence, the new EU medical device regulation was published; it includes the concept of a PMS Plan. Methods This publication reviewed Annex III Technical Documentation on PMS and Annex XIV Part B: Postmarket clinical follow‐up from the new Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices. Results The results of the PMS activities will be described in the PMS plan and will be used to update other related documents. A modular approach to structure the contents of the PMS plan will help to consistently update other PMS information. It is our suggestion that the PMS plan should consist of a PMS plan Core and a PMS plan Supplement. The PMS plan Core document will describe the PMS system, and the PMS plan Supplement will outline the specific activities performed by the manufacturer for a particular medical device. Conclusions The PMS plan may serve as a thorough tool for the benefit‐risk evaluation of medical devices. If properly developed and implemented, it will function as a key player in the establishment of a new framework for proactive safety evaluation of medical devices.

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Section: Pms System For Medicinal Products and Medical Devices In The Eumentioning

confidence: 99%

Section: Medicinal Productsmentioning

confidence: 99%

EU postmarket surveillance plans for medical devices

Pane

Francisca

Verhamme

et al. 2019

Pharmacoepidemiology and Drug

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“…The most commonly reported additional measures used for risk minimization are the educational materials [Zomerdijk et al 2012].…”

Section: Auditmentioning

confidence: 99%

European Union pharmacovigilance capabilities: potential for the new legislation

Borg¹,

Tanti²,

Kouvelas

et al. 2015

Therapeutic Advances in Drug Safety

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European Directives and Regulations introduced between late 2010 and 2012 have substantially overhauled pharmacovigilance processes across the European Union (EU). In this review, the implementation of the pharmacovigilance legislative framework by EU regulators is examined with the aim of mapping Directive 2010/84/EU and Regulation EC No. 1235/2010 against their aspired objectives of strengthening and rationalizing pharmacovigilance in the EU. A comprehensive review of the current state of affairs of the progress made by EU regulators is presented in this paper. Our review shows that intense efforts by regulators and industry to fulfil legislative obligations have resulted in major positive shifts in pharmacovigilance. Harmonized decision making, transparency in decision processes with patient involvement, information accessibility to the public, patient adverse drug reaction reporting, efforts in communication and enhanced cooperation between member states to maximize resource utilization and minimize duplication of efforts are observed.

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“…However, the extent and the rate at which uncertainties are resolved is unknown. Some previous studies focused on the content and quality of the RMP at the moment of approval, 16 , 17 , 18 and the adherence to committed activities over time, 19 but its dynamics in the postapproval phase has not yet been explored.…”

mentioning

confidence: 99%

Risk Management Plans as a Tool for Proactive Pharmacovigilance: A Cohort Study of Newly Approved Drugs in Europe

Vermeer

Duijnhoven

Straus

et al. 2014

Clin Pharmacol Ther

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Risk Management Plans (RMPs) have become a cornerstone in the pharmacovigilance of new drugs in Europe. The RMP was introduced in 2005 to support a proactive approach in gaining knowledge on safety concerns through early planning of pharmacovigilance activities. However, the rate at which uncertainties in the safety profile are resolved through this proactive approach is unknown. We therefore examined the evolution of safety concerns in the RMP after initial approval for a selected cohort of 48 drugs, to provide insight into the knowledge gain over time. We found that 20.7% of the uncertainties existing at approval had been resolved 5 years after approval. Because new uncertainties were included in the RMP at a similar rate, the overall number of uncertainties remained approximately equal. The relatively modest accrual of knowledge, as demonstrated in this study through resolution of uncertainties, suggests that opportunities for optimization exist while ensuring feasible and risk-proportionate pharmacovigilance planning.

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Risk Minimization Activities of Centrally Authorized Products in the EU

Cited by 32 publications

References 20 publications

EU postmarket surveillance plans for medical devices

EU postmarket surveillance plans for medical devices

European Union pharmacovigilance capabilities: potential for the new legislation

Risk Management Plans as a Tool for Proactive Pharmacovigilance: A Cohort Study of Newly Approved Drugs in Europe

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