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Watchdog promises more transparency in drug reviews

Written by | 14 Dec 2012 | All Medical News

by Gary Finnegan – EMA Highlights – The European Medicines Agency has pledged to boost transparency when deciding whether to allow companies to market their medicines for additional conditions.

The Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) agreed to begin publishing information on ongoing applications for extensions of indication of human medicines as part of a wider move to make the regulator’s work more open.

In instances where companies want to change the approved uses of an authorised medicine, they must get the approval of the EMA’s influential Committee for Medicinal Products for Human Use (CHMP). The PRAC offers supporting advice on any changes required to the risk-management plan for the drug in question.

The PRAC, which was established in July 2012, has already started sharing more details of its advice by publishing background details on its assessment of a number of license extensions. These reports appear in the committee’s minutes which are now regularly posted online after each meeting.

The Agency says that by the end of 2013 all of its scientific committees will be publishing agendas and minutes systematically.

Critics of the EMA – including the European Parliament – have frequently been critical of its limited transparency. Manufacturers too have complained that the system can be complex and opaque, although the industry has often accepted that a degree of confidentiality is required when data is commercially sensitive.

EMA Executive Director, Guido Rasi, made greater transparency and user-friendliness one of his priorities when he was appointed in late 2011.

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