EMA

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!'

Tackling medication errors: European Medicines Agency workshop calls for coordinated EU approach

A close collaboration between national patient safety authorities, national competent authorities, the European Medicines Agency, and the European Commission is necessary to tackle the issue of medication errors causing harm in Europe. This collaboration should engage patients and healthcare professionals. This was the conclusion of the workshop on medication errors organised by the Agency from 28 February 2013 - 1 March 2013.

Outcomes of seven years of active support to small and medium-size businesses

Micro, small and medium-sized enterprises (SMEs) that are registered with the SME office of the European Medicines Agency have seen a consistent improvement in the success rate of their marketing-authorisation applications (MAAs) over the past seven years. This is shown in the annual report from the SME office 2012, which analyses the activities of the Agency's SME office since its creation. The Agency put the SME initiative in place in December 2005 to promote innovation and development of medicines by SMEs, as it recognises that SMEs are a major driver of innovation in the pharmaceutical industry.

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