Transatlantic Taskforce on Antimicrobial Resistance reports progress and outcomes of 17 recommendations

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13/05/2014

Transatlantic Taskforce on Antimicrobial Resistance reports progress and outcomes of 17 recommendations

The European Commission and the US Department of Health and Human Services have published today a progress report of the Transatlantic Taskforce on Antimicrobial Resistance (TATFAR). The report outlines the progress and outcomes to date of the 17 recommendations to fight antimicrobial resistance (AMR) that are being implemented by the taskforce.

The European Union (EU) and United States (US) established the TATFAR as a result of the 2009 US-EU summit to intensify cooperation in the fight against AMR.

AMR is a public health problem of increasing magnitude and importance. New antimicrobial agents are urgently needed for a number of human pathogens and very few new classes of antibiotics are under development. Actions are needed on various fronts, both in the human and veterinary areas, and both at global and national levels.

In September 2011, the TATFAR identified and adopted 17 recommendations for areas of future collaboration between the US and EU in the fight against AMR. These recommendations fall into three broad categories:

  • appropriate therapeutic use of antimicrobial medicines in the medical and veterinary communities;
  • prevention of healthcare-associated and community-associated drug-resistant infections;
  • identification of strategies to improve the development pipeline of new antimicrobial agents.

Based on the progress made during the first two years of implementation of the TATFAR recommendations, the mandate of the taskforce was extended in 2013 for two additional years, until 2015.

European Medicines Agency involvement in TATFAR

The European Medicines Agency (EMA) has been involved in the implementation of strategies to foster research and development and facilitate the approval of new safe and effective human antibiotics through a variety of mechanisms. It has cooperated closely with its US counterpart, the Food and Drug Administration (FDA), in these efforts.

“The TATFAR has provided an excellent tool to foster discussion between EMA and FDA on the development of new antibacterial agents for human use”, explains Marco Cavaleri, Head of the EMA’s Anti-infectives and Vaccines office. “It has created a level of mutual understanding between our two Agencies that can ultimately lead to a desirable level of convergence of the regulatory requirements in the two regions.”

The EMA and FDA have established regular meetings and teleconferences during which they discuss recommendations on clinical trial designs for new antibacterial drugs, feasible approaches to facilitate trials and regulatory options available to medicines developers.

On both sides of the Atlantic, guidance for medicines developers has been updated or developed to reflect evolutions in this area.

“The TATFAR has proven to be a useful forum for the exchange of best practice both in the human and veterinary areas”, explains David Mackay, Head of the EMA’s Veterinary Medicines Division. “It has also been a useful platform to discuss appropriate measures to limit risks to man that could result from the use of antimicrobial medicines in animals.”

An additional recommendation has been added to the existing 17 recommendations of the TATFAR to address this particular issue, especially to identify the knowledge gaps that exist with respect to the transmission of antimicrobial resistance from animals to man and how this can best be controlled. The TATFAR has already demonstrated that it provides an effective forum for facilitating transatlantic cooperation to address such knowledge gaps with respect to AMR.

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