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EMA brings transparency to its committee proceedings

Publishes meeting minutes of CHMP and two other advisory groups

European Medicines Agency (EMA)The European Medicines Agency (EMA) has, for the first time, brought a measure of transparency to the way its key scientific advisory committee works.

For the first time the regulator has published meeting minutes for the Committee for Medicinal Products for Human Use (CHMP), which issues advice on which pharmaceutical products to approve.

It's the final stage in a move to greater transparency around its advisory committees from the regulator and sees the some of the workings of two other committees put online too for the first time.

These are the EMA's Committee for Advanced Therapies (CAT), which covers areas such as gene therapies, cell therapies and tissue-engineered products in animals, and its Committee for Medicinal Products for Veterinary Use (CVMP).

The first published minutes come from the December CHMP, CAT and CVMP meetings, following their adoption at their January meetings.

The EMA said it would now “routinely publish” agendas for all seven of its scientific committees at the start of their meetings and follow this with publication of the meeting minutes after their adoption, which generally occurs in the following month.

The minutes record all the topics discussed during the meetings. However, the EMA notes that “some of the information contained in these minutes is considered commercially confidential or sensitive and therefore not disclosed”. The information not provided includes “certain aspects” of on-going CHMP discussions.

The Agency will now routinely publish all agendas at the start of each committee meeting and the minutes after their adoption, usually the following month.

The EMA said its latest scientific committee publications “completes a major transparency initiative initiated by the Agency in July 2012”.

However, the transparency debate has widened considerably since the EMA began its deliberations and how to deal with access to trial data remaining a sticking point between the industry and its critics.

The EMA has previously said the move towards greater clinical trial transparency is “irreversible”, but it continues to face criticism in this area.

Just last year the agency was accused of withholding pertinent information on a drug that was withdrawn from sale on safety grounds in 2008 and subsequently returned to market in 2012.

Read: Minutes of CHMP's December meeting

Read: Minutes of CAT's December meeting

Article by
Dominic Tyer

29th January 2014

From: Regulatory



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