EMA

European Medicines Agency starts safety review of Diane 35 and its generics

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) formally started a safety review of Diane 35 (cyproterone acetate 2 mg, ethinylestradiol 35µg), associated names and its generics at its 4 - 7 February 2013 meeting. The Europe-wide review has been initiated at the request of the French medicines regulatory agency (ANSM), following the announcement of its plan to suspend the marketing authorisations for Diane 35 and its generics for acne treatment in France over the next three months.

European Medicines Agency to review third- and fourth-generation combined oral contraceptives

The European Medicines Agency has been asked by France to review third- and fourth-generation combined oral contraceptives to determine whether there is a need to restrict the use of these medicines to women who cannot take other combined oral contraceptives. France has made this request amid recent initiatives to reduce the use of third- and fourth-generation combined oral contraceptives by French women in favour of using second-generation oral contraceptives.

European Medicines Agency confirms recommendation to suspend Tredaptive, Pelzont and Trevaclyn

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has confirmed the recommendation to suspend the marketing authorisations of Tredaptive, Pelzont and Trevaclyn (nicotinic acid / laropiprant) used to treat adults with dyslipidaemia (abnormally high blood levels of fats such as triglycerides and cholesterol). The CHMP decision follows the recent recommendation by the Pharmacovigilance Risk Assessment Committee (PRAC) to suspend these medicines. The marketing-authorisation holder, Merck Sharp & Dohme Ltd, has, in the meantime, announced that it is taking steps to suspend availability of the medicines across the European Union (EU).

eSubmission Gateway release II and eSubmission web client now live for all applications for human medicines

The European Medicines Agency's Gateway release II and the eSubmission web client are now live for all applications for centralised procedure marketing authorisation for human medicines. Gateway release II is an upgraded version of eSubmission Gateway, the electronic submission channel that the Agency launched in 2012 to allow applicants to submit documents supporting all types of applications for human medicines to the Agency securely over the internet in the Electronic Common Technical Document (eCTD) format.

European Medicines Agency updates guideline on evaluation of anticancer medicines

The European Medicines Agency has finalised the revision of its guideline on the evaluation of anticancer medicinal products. This revision includes, amongst other topics: the use of biomarkers as an integrated part of the development of medicines, combination therapy studies, and the choice of endpoints in confirmatory trials. The Agency is responsible for the evaluation of all new anticancer medicines in the European Union. The guideline provides guidance on all stages of clinical drug development for the treatment of cancer.

European Medicines Agency update on combined contraceptives

The European Medicines Agency is issuing this update in response to growing media reports about combined contraceptives and venous thromboembolism (blood clots in veins). It is well-established that combined contraceptives carry a very rare risk of blood clots, and that the risk differs between types of combined contraceptives. These products are constantly and rigorously kept under close monitoring.

European Medicines Agency reviews its operations and prepares for reorganisation in 2013

The European Medicines Agency has begun a review of its operations and processes, focused on increasing the efficiency of its scientific activities and information- and communication-technology operations. As part of this process, it will focus on the support provided to the Agency's scientific committees to help them deliver high-quality, consistent opinions. The Agency expects this process to result in a significant reorganisation of its staff during 2013.

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