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Compliance In Focus
Posted by John Lehmann on Thu, Apr 26, 2012

Who is Better Organized: The FDA or EMA?

A new committee has been established by the European Medicines Agency (EMA), called theFDA EMA Organization Scientific Coordination Board. According to a press-release, the group aims to ensure “sufficient coordination between the committees, so that the standards they set for the development of medicines are consistent across the whole product life-cycle, for increased robustness and predictability of benefit-risk assessment.”

The EMA also stated plans for the board to look into factors that may be “putting the system under pressure.” The issues including:

  • Increasing difficulties in sourcing appropriate experts due to the continuous strengthening of the rules on allowable conflicts of interests of the Agency’s experts
  • The continuous increase in the number and level of activities for all committees
  • Challenges from new scientific developments, for instance advanced therapies or personalized medicines, which require an integrated scientific and regulatory approach, from the drug development phase, starting with scientific advice, right through to post-authorization follow-up

One of the fundamental reasons why the EMA found a need for such a group is because of the Agency’s increasing complexity. In fact, according to EMA’s Executive Director, Guido Rasi, “We now have six scientific committees, plus two scientific advice working parties, one for human, one for veterinary medicines.” And a new committee will start in July.  “The complexity of the system has increased to a point where we have to ask ourselves if it is still fit for purpose. We have set up this new group so that we can analyze together the working methodology of the system so far, identify weaknesses or gaps in the system and discuss ways to address these.”

The FDA’s organizational map is slightly different then that of the EMA. According to the website the FDA is an agency within the U.S. Department of Health and Human Services. It consists of six product centers (biologics, devices & radiological health, drugs, good safety, tobacco products, veterinary medicine) one research center, and two offices.

Take a look at the FDA’s offices, and at the EMA’s offices.  Do you think the FDA could benefit from a “Scientific Coordination Board” to act as an umbrella over all? Do you prefer the organization of the FDA or the EMA? Share your thoughts below.

Photo credit: csuspect

Topics: European Medicines Agency (EMA), FDA


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