EMA

European Medicines Agency formalises interaction with healthcare professionals

European Medicines Agency (EMA)

The European Medicines Agency has set out its plans to establish regular interaction with a network of European organisations representing doctors, nurses and pharmacists. In the framework for interaction between the European Medicines Agency and healthcare professionals, published today, the Agency describes its plans to:

European Medicines Agency and United States Food and Drug Administration to share manufacturing site inspections

European Medicines Agency (EMA)

The European Medicines Agency and the United States Food and Drug Administration (FDA) are launching an initiative to share work on inspections of manufacturing sites in each other's territories. The initiative, starting in January 2012, will enable the two authorities to rely on each other's inspection outcomes rather than carrying out separate inspections in duplicate. This is expected to:

World AIDS Day: 1 December 2011

European Medicines Agency (EMA)

The European Medicines Agency supports World AIDS Day, which is taking place today Thursday 1 December 2011. World AIDS Day is held each year on 1 December and is an opportunity to raise awareness, commemorate those who have passed on, and celebrate victories such as increased access to treatment and prevention services. In 2011, the theme is "getting to zero".

European Medicines Agency hosts first workshop on subgroup analysis

European Medicines Agency (EMA)

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

European Medicines Agency (EMA)

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

European Medicines Agency (EMA)

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

European Medicines Agency (EMA)

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:

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