EMA

Update on ongoing European review of pioglitazone–containing medicines

The European Medicines Agency (EMA) has been informed by the French Medicines Agency (Afssaps) of its decision to suspend the use of pioglitazone-containing medicines in France (Actos, Competact), while awaiting the outcome of the ongoing European review on the benefits and risks of these antidiabetic medicines. This decision by the French authority follows receipt of results of a retrospective cohort study carried out in France.

European Medicines Agency responds to criticism over transparency in British Medical Journal

The European Medicines Agency has responded to an article published in the British Medical Journal (BMJ) that called for more transparency by medicines regulatory authorities. The letter, which was published on the BMJ's website on Friday 13 May, outlines the steps that the Agency has taken to increase its transparency since its establishment in 1995.

European Medicines Agency recommends interim measures for Pandemrix

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended that the product information for Pandemrix should be amended to advise prescribers to take into account preliminary results from epidemiological studies on Pandemrix and narcolepsy, and to perform an individual benefit-risk assessment when considering the use of Pandemrix in children and adolescents. This is an interim measure pending the outcome of the European review, expected to conclude in July 2011.

Recommendations on labelling and packaging for non-prescription medicines released for consultation

The European Medicines Agency has released recommendations on pack design and labelling for centrally authorised non-prescription human medicinal products for a three-month public consultation period. The draft document summarises recommendations for companies preparing mock-ups and specimens of the packaging of non-prescription medicines authorised through the centralised procedure.

EU Clinical Trials Register goes live

The EU Clinical Trials Register was launched by the European Medicines Agency (EMA). The online register gives for the first time public access to information on interventional clinical trials for medicines authorised in the 27 EU Member States and Iceland, Liechtenstein and Norway. The database also allows the public to search for information on clinical trials authorised to be carried out outside the EU if these trials are part of a paediatric investigation plan.

European Medicines Agency and U.S. Food and Drug Administration announce pilot program

The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) are launching a three-year pilot program that will allow parallel evaluation of relevant quality data components, known as Quality by Design (QbD), of selected applications that are submitted to both agencies at the same time. The pilot will be starting on 1 April 2011.

Public statement on Thelin: Withdrawal of the marketing authorisation in the European Union

On 10 August 2006 the European Commission granted a marketing authorisation for the whole European Union for Thelin (sitaxentan), an endothelin receptor antagonist used to treat adults (aged 18 years or over) with pulmonary arterial hypertension to improve exercise capacity (the ability to carry out physical activity) in patients with class III disease. Thelin was marketed in 16 EU Member States.

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