European Medicines Agency Now Publishing Meeting Agendas for All Scientific Committees - Applied Clinical Trials

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European Medicines Agency Now Publishing Meeting Agendas for All Scientific Committees

Source: Company News Release

The European Medicines Agency (EMA) is publishing, for the first time, the agendas of the Committee for Medicinal Products for Human Use (CHMP), the Committee for Medicinal Products for Veterinary Use (CVMP) and the Committee for Advanced Therapies (CAT). The minutes of each of these meetings held in December will be published once they have been adopted by the relevant Committee at its meeting in January. It will then be standard practice to publish the agendas at the start of each meeting and the minutes after their adoption the following month.

This follows last week’s Management Board meeting, which cleared the way for the publication of the agendas and minutes of these three remaining EMA scientific committees. It is the final step of a process launched by the Agency in July 2012 that has already been implemented for its four other scientific committees.

“Openness of our operations is one of my key objectives. As part of this, we promised in July 2012 to start publishing agendas and minutes of all seven of our scientific committees by the end of 2013, and we are now delivering on this objective. Achieving our plan for all committees, including those giving recommendations on the marketing authorisation of medicines, the CHMP and CVMP, is a major milestone in this transparency initiative,” said Guido Rasi, Executive Director of the EMA.

“We see transparency as a priority as it is the basis for public confidence and trust in the Agency and the European Union system for the evaluation of medicines,” he added.

The Agency started publishing the agendas and minutes of its scientific committee meetings with the Pediatric Committee (PDCO) and the Pharmacovigilance Risk Assessment Committee (PRAC) in July 2012, followed by the Committee for Orphan Medicinal Products (COMP) in September 2012 and the Committee on Herbal Medicinal Products (HMPC) in September 2013.

Notes

  1. This press release, together with all relevant documents is available on the Agency's website.
  2. The CHMP and CAT agendas include an explanatory note which outlines the main sections and headings in both agendas.
  3. The principles for publication of agendas and minutes of EMA scientific committees will be published on the Agency’s website here: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/events/2012/06/event_detail_000587.jsp&mid=WC0b01ac058004d5c3
  4. The July 2012 press release announcing the Agency’s plan to publish committee agenda and minutes is available here: http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2012/07/WC500130054.pdf
  5. More information on the December Management Board meeting is available in separate press releases.
  6. More information on the work of the European Medicines Agency can be found on its website: www.ema.europa.eu

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