The European Medicines Agency has published a report of the workshop held on 26 September 2013 to discuss further development of patient involvement in the evaluation of medicines, in particular in the assessment of benefit and risk that lies at the heart of the regulatory process.
This document provides a non-exhaustive overview of the potential pre-defined factors that can be used for the selection of marketing authorisation applications (MAAs) to be part of a programme of routine inspections and non-exhaustive overview of potential triggers that can be detected at the different stages of the assessment process and that can help the assessor to decide on the need for “for cause” inspections and be used to prepare an inspection.
The Pharmacovigilance Risk Assessment Committee (PRAC) has marked the successful completion of its first year of operation.
The PRAC also welcomed the full involvement of Croatia in its activities at its July 2013 meeting following the accession of Croatia to the European Union (EU) on 1 July 2013. Croatian delegates have been observers of the PRAC since it began its operations in July 2012.
The European Medicines Agency has launched its website on suspected side-effect reports for medicines authorised in the European Economic Area (EEA) in the remaining 22 official European Union (EU) languages.
The report shows continuously high levels of activities in almost all of the Agency’s business areas. There was a slight increase in the number of applications for initial marketing authorisations for medicines for human use, from 91 applications in 2010 to 100 applications in 2011. Most of this increase was due to applications received for new medicines: this number rose by over 40% from 34 in 2010 to 48 in 2011
The European Medicines Agency has revised the rules on fees payable to the Agency. The revised rules, which come into force on 4 August 2013, provide for full waiver of fees for pharmacovigilance-related type-IA (immediate-notification) variations to the terms of marketing authorisations with the following scopes:
C.I.8, i.e. introduction of, or changes to, a summary of pharmacovigilance system for medicinal products for human use;
C.I.10, i.e. change in the frequency or date of submission of periodic safety update reports (PSURs) for human medicinal products;
C.I.12, i.e. inclusion or deletion of the black symbol and explanatory statements for medicinal products in the list of medicinal products that are subject to additional monitoring;
C.I.z, i.e. inclusion of the statements of adverse-drug-reaction reporting.
A close collaboration between national patient safety authorities, national competent authorities, the European Medicines Agency, and the European Commission is necessary to tackle the issue of medication errors causing harm in Europe. This collaboration should engage patients and healthcare professionals. This was the conclusion of the workshop on medication errors organised by the Agency from 28 February 2013 – 1 March 2013.
This position paper is intended to provide guidance on how potential medication errors should be addressed in the context of benefit-risk balance assessment and risk minimisation measures. Specifically, the paper focuses on potential medication errors caused by confusion of a newly introduced medicinal product with established medicines that contain the same active substance and are similar in appearance or name but different in some other attributes such as strength, dosing or route of administration.
On this website you can view data on suspected side-effects also known as suspected adverse drug reactions for authorised medicines in the European Economic Area (EEA).
This data is presented in a format called a web report.
Currently the data only relates to medicines approved through the centralised authorisation procedure.
The information on this website relates to suspected side effects, i.e. medical events that have been observed following the use of a medicine, but which are not necessarily related to or caused by the medicine.
Information on suspected side effects should not be interpreted as meaning that the medicine or the active substance causes the observed effect or is unsafe to use. Only a detailed evaluation and scientific assessment of all available data allows for robust conclusions to be drawn on the benefits and risks of a medicine.
The European Medicines Agency publishes this data so that its stakeholders, including the general public, can access information that European regulatory authorities use to review the safety of a medicine or active substance. Transparency is a key guiding principle of the Agency.