EMA Shines a Light into its Black Boxes of Regulatory: Its Review Committee Meetings

Posted 29 January 2014 | By Alexander GaffneyRAC

US regulatory professionals have long benefited from meeting transcripts and other open meeting requirements that have meant that the inner workings and decisions of the US Food and Drug Administration's (FDA) various advisory committees are available for debate and dissection.

Background

This can be extremely useful for a range of stakeholders. Regulatory professionals seeking approval for similar products can tailor their applications to address the needs of committee members; Public safety advocates can flag potential issues with the safety of a drug; Competitors can learn more about trial designs and the outcomes of studies.

But in the EU, the European Medicines Agency's (EMA) various formal review committees have never been as transparent as FDA's. Regulatory professionals hoping for an insight into how EMA's Committee for Medicinal Products for Human Use (CHMP), Committee for Medicinal Products for Veterinary Use (CVMP) or Committee for Advanced Therapies (CAT), have previously been forced to speculate about matters of discussion at their respective committee meetings.

EU Changes

Now that speculation is slated to become a bit less speculative, and a bit more informed.

In a 28 January 2014 announcement, EMA said that for the first time ever it has published the meeting minutes of all three committees, providing the public (and regulatory professionals) with a look into what goes on inside its regulatory black boxes.

"The publication of the minutes of these three scientific committees completes a major transparency initiative initiated by the Agency in July 2012 to publish the agendas and minutes for the meetings of all seven of its scientific committees," EMA wrote in a statement.

But if you're looking for an in-depth play-by-play account of the meeting, you're likely to still be disappointed. The meeting minutes are generally vague, glossing over the nuance that marks most regulatory decisions in favor of more sweeping, aggregated statements of the committee's actions.

"The CHMP discussed the update" is a phrase which is repeated many times within the CHMP's first update, offering little in the way of insight into a particular decision. However in other sections, such as Section 12.4, EMA provides significant details into the information it took into account in coming to a decision.

Redacted Information

Some information is also redacted from the reports. For example, requests for good manufacturing, clinical, laboratory and pharmacovigilance practice inspections have all been redacted, with EMA stating that disclosing this information would "undermine the purpose of such inspections," presumably because they have not yet occurred.

EMA said it will now "routinely publish" agendas from the CHMP, CVMP, and CAT at the beginning of each month, and the minutes of each meeting in the month following the meeting.

 

EMA Statement


Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe