EMA

European Medicines Agency issues six key recommendations to tackle the issue of medication errors

The European Medicines Agency (EMA) has issued six key recommendations to tackle the issue of medication errors causing harm in the European Union (EU). These recommendations are described in the medication-errors workshop report. This workshop was held by the Agency from 28 February to 1 March 2013 to raise awareness of this important public-health issue. The Agency, in collaboration with the European Commission and the EU regulatory network, will now develop an action plan, which it will publish before the end of the year.

European Medicines Agency simplifies processing of fee reductions for orphan medicines

The European Medicines Agency has cancelled the procedure by which sponsors of medicines with an orphan designation need to inform the Agency of their intention to submit an application in order to be eligible for a fee reduction. This forms part of the Agency's effort to reduce administrative burden for applicants and streamline the procedures for fee reductions. Medicines that have been granted orphan designation by the European Commission on the recommendation of the Agency's Committee for Orphan Medicinal Products (COMP) are eligible for fee reductions for a range of regulatory activities.

Recommendation to suspend tetrazepam-containing medicines endorsed by CMDh

Following the recent recommendation by the Pharmacovigilance Risk Assessment Committee (PRAC), the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) has endorsed by majority the PRAC recommendation to suspend the marketing authorisations of tetrazepam-containing medicines across the European Union (EU). The CMDh, a body representing EU Member States, is responsible for ensuring harmonised safety standards for medicines authorised via national marketing authorisation procedures across the EU.

Stem cell therapy treatments

Concerns have been raised in the media about certain stem cell therapy treatments. These sorts of new techniques potentially offer exciting possibilities to patients for the treatment of a range of difficult or previously untreatable conditions. Like all treatments, these techniques also come with benefits and risks. Specific rules were introduced in the European Union (EU) in 2007 to ensure that medicines involving cell therapy are subject to appropriate authorisation, supervision and controls in order to reduce and manage those risks.

European Medicines Agency publishes report on patient recruitment and geographical location of clinical trials

Almost 62% of the patients in pivotal trials submitted in marketing-authorisation applications (MAAs) to the European Medicines Agency between January 2005 and December 2011 were recruited outside of the European Economic Area (EEA) and Switzerland, according to an analysis performed by the Agency. The report on clinical trials submitted in MAAs to the European Medicines Agency provides an overview of the distribution of the numbers of patients, investigator sites and pivotal clinical trials included in MAAs submitted to the Agency, as well as the number and location of sites that were inspected.

European Medicines Agency recommends restricting use of cilostazol-containing medicines

The European Medicines Agency's Committee on Medicinal Products for Human Use (CHMP) has recommended that the use of cilostazol-containing medicines in the treatment of intermittent claudication - a condition where poor blood supply to the leg muscles causes pain and affects the ability to walk - should be restricted with a range of new measures aimed at targeting a patient population in which there are clinical benefits, and at the same time minimising important risks.

World Kidney Day: 'Acute kidney injury: stop kidney attack!'

World Kidney Day is held every year in March to raise awareness of the importance of the kidneys to overall health and to reduce the frequency and impact of kidney disease and its associated health problems worldwide. The Day is a joint initiative of the International Society of Nephrology (ISN) and the International Federation of Kidney Foundations (IFKF). In 2013 World Kidney Day is focusing on acute kidney injury with the theme: 'Acute kidney injury: stop kidney attack!'

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