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European Medicines Agency hosts first workshop on subgroup analysis

On 18 November 2011, the European Medicines Agency assembled for the first time some 50 experts in subgroup analysis from Europe and the United States, in a one-day scientific workshop. The experts included representatives from regulatory authorities, a health-technology-assessment agency, academia and pharmaceutical industry, and discussed standards and methodology for the planning, conducting and reporting of subgroup analysis.

European Medicines Agency invites registrations for eSubmission Gateway

The European Medicines Agency is inviting pharmaceutical companies to register to take part in a three-month pilot of its eSubmission Gateway, beginning on 9 January 2012. The eSubmission Gateway is a new electronic submission channel that applicants will be able to use to submit applications for centralised marketing authorisations for human medicines in the Electronic Common Technical Document (eCTD) format. This includes new applications, supplementary information, variations and renewals of marketing authorisation.

European Medicines Agency updates on safety of Pradaxa

The European Medicines Agency is providing an update on the safety of the anticoagulant medicine Pradaxa (dabigatran etexilate). Pradaxa has been authorised since March 2008 for primary prevention of venous thromboembolic events in adults who have had elective total hip replacement surgery or total knee replacement surgery. Since August 2011, it is also authorised for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation. The efficacy of Pradaxa as demonstrated in clinicial trials remains unchanged.

European Medicines Agency simplifies SME assignment process

The European Medicines Agency has introduced a simplified process for handling requests from companies that wish to register as micro, small or medium-sized enterprises (SMEs). The new process, which is based on more than five years of experience of working with SMEs, is expected to reduce the administrative burden on companies and to speed up the SME assignment and renewal process. The simplifications include:

European Medicines Agency starts new review of cardiovascular risks of non-selective NSAIDs

The European Medicines Agency is reviewing the latest available data on the cardiovascular safety of non-selective NSAIDs (non-steroidal anti-inflammatory drugs). NSAIDS have been the subject of several European reviews in relation to gastrointestinal and cardiovascular safety and the occurrence of serious skin reactions. At the outcome of the last review on the cardiovascular safety of non-selective NSAIDs, in 2006, the Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the overall benefit-risk balance remained positive, but the possibility of a small increased risk of thrombotic events such as heart attacks or stroke with non-selective NSAIDs could not be excluded.

European Medicines Agency launches database of clinical studies in children completed before 2007

The European Medicines Agency has published a new database containing information on studies of medicines authorised in the European Union that were carried out in children and completed before the Paediatric Regulation came into force in 2007. The Article 45 paediatric studies database allows users to search for information on the studies’ names and aims, the medicines studied and the ages of patients included. For a subset of studies, documents summarising the study’s results are also available.

European Medicines Agency launches new database of European experts

Coinciding with the entry into force of new rules on how to handle conflicts of interests of scientific experts, the European Medicines Agency launched its new experts database. The database allows the public for the first time to directly search for the declarations of interests of all experts who have been nominated by competent authorities for medicines regulation across the European Union to be involved in the Agency's activities.

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