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EMA boosts transparency efforts with plans to publish all committee minutes

Will begin with Paediatric Committee meeting

The European Medicines Agency (EMA) has continued efforts to improve transparency in the organisation by announcing plans to publish all agendas and minutes of its scientific committees.

The initiative, announced by the Agency's executive directors Guido Rasi, will begin with the publication of the agenda and minutes of the Paediatric Committee (PDCO) – the EMA's committee responsible for assessing the content of data obtained through studies involving children to support the authorisation of paediatric indications for medicines.

Continuing the process, the next group set to share its agenda and minutes is the EMA's newest committee, the Pharmacovigilance Risk Assessment Committee (PRAC), formed as part of plans to overhaul the system for reporting and monitoring drug safety concerns in Europe.

The remaining committees, including the Committee for Medicinal Products for Human Use (CHMP) and the Committee for Orphan Medicinal Products (COMP), will follow suit in a phased approach with the EMA planning to systematically publish all of its committees' agendas and minutes before the end of 2013.

“I have made increased transparency one of my key priorities since my appointment as executive director in November, 2011,” said Professor Rasi.

“This latest initiative is an important part of opening up our operations, to reinforce the trust and reputation of the Agency as a public health body.”

Transparency has been an increasing priority for the EMA in recent years, with the drugs industry coming under greater scrutiny following several major scandals.

These include the decision to withdraw GlaxoSmithKline's diabetes drug Avandia after it was linked to heart problems, as well as the withdrawal of Servier's weight loss drug Mediator – an incident that led to the launch of a new drugs regulatory body in France.

As with the EMA's other publicly released documents, agendas and minutes will be redacted to protect certain confidential information and personal data.

19th July 2012


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