Improving patient safety through more proactive risk management

 

  • Revised good pharmacovigilance practices module on risk management systems released for public consultation

 

London, UK (February 29, 2016) – The European Medicines Agency (EMA) has published today a revision of module V of the good pharmacovigilance practices (GVP) on risk management systems for public consultation until 31 May 2016.


Risk management is a major component of the safety monitoring of medicines. Risk management entails putting in place measures to minimise potential risks and to fill knowledge gaps for medicines (e.g. through post-authorisation data). The goal is to ensure that throughout its lifespan the benefits of a particular medicine exceed the risks by the greatest achievable margin. Marketing authorisation holders are required to present the proposed activities in a risk management plan (RMP) that needs to be approved by the regulators before a medicine can be authorised.

 

GVP module V, released in 2012, advises developers of medicines, marketing authorisation holders and regulators on the design of effective risk management systems and plans. This first major revision is based on the experience gained since the Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) started its operations, which includes the review of risk management plans. It further clarifies the activities a risk management plan should focus on during the life cycle of a product. This will help to ensure that a risk-proportionate planning of activities directs resources to areas where the need for additional information and risk minimisation is greatest. GVP module V highlights principles of risk minimisation and therefore, should be read in conjunction with GVP module XVI which focuses on tools for risk minimisation.

 

Together with the GVP module V, EMA is also consulting stakeholders on an amended RMP template, to be used by medicine developers. The revision of the RMP template is based on the principles described in the updated GVP module V in the view of getting a focussed risk management system and simplifying the way information is submitted to the regulators. The RMP template includes a format for a summary of the RMP to be made public, and this format incorporates improvements following a one-year pilot phase. The RMP summary aims at further streamlining and contextualising the information and to better meet the information needs and expectations of interested stakeholders.

 

Comments on the GVP module V should be provided using this template. The completed comments form should be sent to gvp@ema.europa.eu by 31 May 2016.

 

Comments on the RMP template should be provided using this template. The completed comments form should be sent to rmptemplate@ema.europa.eu by 31 May 2016.

 

After comments have been received from stakeholders during the public consultation, the Agency will publish the final versions of the GVP module V and the RMP template together with an implementation plan. Until this time the current versions of the GVP module V and the RMP template remain applicable.

 

GVP modules are a set of guidelines to facilitate and strengthen pharmacovigilance in the EU. They apply to marketing authorisation holders, the Agency and medicines regulatory authorities in EU Member States and aim to improve safety for patients. They cover medicines authorised centrally via the Agency as well as medicines authorised at national level.

 

The release of the GVP modules is a key deliverable of the 2010 pharmacovigilance legislation. Each module was developed by a team of experts from the Agency and from EU Member States.

 

 


European Medicines Agency (EMA), 29.02.2016 (tB).

MEDICAL NEWS

IU School of Medicine researchers develop blood test for anxiety
COVID-19 pandemic increased rates and severity of depression, whether people…
COVID-19: Bacterial co-infection is a major risk factor for death,…
Regenstrief-led study shows enhanced spiritual care improves well-being of ICU…
Hidden bacteria presents a substantial risk of antimicrobial resistance in…

SCHMERZ PAINCARE

Hydromorphon Aristo® long ist das führende Präferenzpräparat bei Tumorschmerz
Sorgen und Versorgen – Schmerzmedizin konkret: „Sorge als identitätsstiftendes Element…
Problem Schmerzmittelkonsum
Post-Covid und Muskelschmerz
Kopfschmerz bei Übergebrauch von Schmerz- oder Migränemitteln

DIABETES

Wie das Dexom G7 abstrakte Zahlen mit Farben greifbar macht…
Diabetes mellitus: eine der großen Volkskrankheiten im Blickpunkt der Schmerzmedizin
Suliqua®: Einfacher hin zu einer guten glykämischen Kontrolle
Menschen mit Diabetes während der Corona-Pandemie unterversorgt? Studie zeigt auffällige…
Suliqua® zur Therapieoptimierung bei unzureichender BOT

ERNÄHRUNG

Positiver Effekt der grünen Mittelmeerdiät auf die Aorta
Natriumaufnahme und Herz-Kreislaufrisiko
Tierwohl-Fleisch aus Deutschland nur mäßig attraktiv in anderen Ländern
Diät: Gehirn verstärkt Signal an Hungersynapsen
Süßigkeiten verändern unser Gehirn

ONKOLOGIE

Strahlentherapie ist oft ebenso effizient wie die OP: Neues vom…
Zanubrutinib bei chronischer lymphatischer Leukämie: Zusatznutzen für bestimmte Betroffene
Eileiter-Entfernung als Vorbeugung gegen Eierstockkrebs akzeptiert
Antibiotika als Störfaktor bei CAR-T-Zell-Therapie
Bauchspeicheldrüsenkrebs: Spezielle Diät kann Erfolg der Chemotherapie beeinflussen

MULTIPLE SKLEROSE

Multiple Sklerose: Aktuelle Immunmodulatoren im Vergleich
Neuer Biomarker für Verlauf von Multipler Sklerose
Multiple Sklerose: Analysen aus Münster erhärten Verdacht gegen das Epstein-Barr-Virus
Aktuelle Daten zu Novartis Ofatumumab und Siponimod bestätigen Vorteil des…
Multiple Sklerose durch das Epstein-Barr-Virus – kommt die MS-Impfung?

PARKINSON

Meilenstein in der Parkinson-Forschung: Neuer Alpha-Synuclein-Test entdeckt die Nervenerkrankung vor…
Neue Erkenntnisse für die Parkinson-Therapie
Cochrane Review: Bewegung hilft, die Schwere von Bewegungssymptomen bei Parkinson…
Technische Innovationen für eine maßgeschneiderte Parkinson-Diagnostik und Therapie
Biomarker und Gene: neue Chancen und Herausforderungen für die Parkinson-Diagnose…