Which databases are used by EMA for medical literature monitoring?
Databases used EMBASE, covering literature from EEA and non-EEA countries; EBSCO, covering a wide range of resources, mainly focusing on: International Pharmaceutical Abstracts (IPA); The Allied and the Complementary Medicine Database (AMED).
What are GVP guidelines?
Good pharmacovigilance practices (GVP) are a set of measures drawn up to facilitate the performance of pharmacovigilance in the European Union (EU). GVP apply to marketing-authorisation holders, the European Medicines Agency (EMA) and medicines regulatory authorities in EU Member States.
What is MLM literature?
The Agency shall monitor selected medical literature for reports of suspected adverse reactions to medicinal products containing certain active substances. It shall publish the list of active substances being monitored and the medical literature subject to this monitoring. 2.
How frequently does literature searching have to be performed in the EU?
Global and Local Literature Screening Within the European Union, it is required that upon submission of a MA application, the MAH will conduct at least weekly searches of the global literature to identify any emerging safety information.
Who ensures that the literature review includes the use of reference database?
B. 1.1. 2. “Literature reports” are further specified following: “The marketing authorisation holder should ensure that the literature review includes the use of reference databases that contain the largest reference of articles in relation to the medicinal product properties5.
What is PV literature monitoring?
Pharmacovigilance (PV) Literature Monitoring. It gives any organisation tasked with drug safety reporting a streamlined, efficient and compliant approach to the entire literature triage process.
What is PSMF pharmacovigilance?
The pharmacovigilance system master file (PSMF) is a detailed description of the pharmacovigilance system used by the MAH with respect to one or more authorised medicinal products. The PSMF is not part of the marketing authorisation (MA) dossier and is maintained independently from the MA.
What is pharmacovigilance literature case?
“Scientific & medical literature is a significant source of information for the monitoring of the safety profile and of the risk benefit balance of medicinal products, particularly in relation to the detection of new safety signals or emerging safety issues.” Literature report is any adverse drug reactions reported in.
What is literature surveillance in pharmacovigilance?
The EMA is responsible for monitoring selected medical literature and for entering identified reports of suspected adverse reactions in EudraVigilance. The clock for reporting starts (Day 0) with awareness of a publication containing the minimum information for reporting.
What is local literature search?
Local Literature Screening (LLS) is performed by screening the journals which are not included in biomedical databases used during global literature screening. Those journals are considered non-indexed literature. Some countries have specialized local databases that help shorten the process of journal selection.
What is literature review in pharmacovigilance?
5 Considerations for a New Pharmacovigilance Literature Review Workflow. Scientific literature is one of the most significant sources of information to monitor the safety profile and the risk-benefit balance of medicinal products, particularly in relation to detecting new or emerging safety signals or issues.
How does EMA’s medical literature monitoring service work?
Individual case safety reports (ICSRs) resulting from EMA’s medical literature monitoring service follow this process: Electronic transmission to the EudraVigilance Gateway. Rerouting to national competent authorities in EEA Member States. Made available to concerned marketing authorisation holders via the ICSR download area of EVWEB.
When was the EMA gene therapy guideline released?
Released for Consultation: May 2008. Guideline on the non-clinical studies required before first clinical use of gene therapy medicinal products (EMEA/CHMP/GTWP/125459/06). This guideline defines scientific principles and provides guidance to applicants developing gene therapy medicinal products (GTMPs).
Do you have to report adverse reactions to EMA?
Marketing authorisation holders should note that they are required to monitor and report to EudraVigilance suspected adverse reactions: recorded in medical literature that EMA does not monitor as part of its service, including for active substances that are covered by EMA’s service.
When did the EMA directive come into effect?
Guidance is given on application of the methodology laid down in the Directive 2001/18/EC on the deliberate release of genetically modified organisms into the environment. Date for coming into effect: November 2008.