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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.

Committee for Orphan Medicinal Products - strengthened interactions with patients and international partners

"The European Medicines Agency's Committee for Orphan Medicinal Products (COMP) is stepping into another stage of its role in the lifecycle of orphan medicines and in the field of rare diseases, after the first 12 years of the implementation of the Orphan-Medicinal-Product Regulation in the European Union," explains Bruno Sepodes, chair of the COMP. Integrating the views of patients, expanding international cooperation and collaborating with health-technology-assessment (HTA) bodies for a better understanding of orphan designation are some of the topics the COMP will focus on this year.

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.

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