Regulatory Focus™ > News Articles > EMA Issues Guidelines on Development of Antibacterials

EMA Issues Guidelines on Development of Antibacterials

Posted 09 January 2012 | By Alexander Gaffney, RAC 

The European Medicines Agency (EMA) today released a guideline titled, Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections. The document was approved last month at the 15 December 2011 meeting of the Committee for Medicinal Products for Human Use (CHMP) meeting, and is due to come into effect on 15 January 2012.

The guideline was formulated by EMA to further clarify aspects of the antibacterial agent development process that prior guidelines did not adequately address. In particular, the new guideline provides details on the requirements of clinical testing for antibacterial agents used against rare, difficult and drug-resistant pathogens.

The new guideline clarifies:

  • how to identify the antibacterial's mechanism of action;
  • how to identify the antibacterial's efficacy against drug-resistant infections;
  • how to determine the long-term efficacy, possible susceptibility to bacterial resistance, and safety of an antibacterial;
  • the proper dosing for antibacterials, including how to conduct dose-finding studies in adults and children;
  • the clinical studies necessary to support particular indications;
  • the types of clinical trials necessary to support antibacterial safety and efficacy claims, and when exemptions may be sought;
  • how to test the safety and efficacy of an antibacterial against rare, multi-drug resistant, or difficult pathogens; and
  • how to specify the indications of an antibacterial agent on its Summary of Product Characteristics (SmPC).

The guidelines note that further clarification in the form of addendums is forthcoming.


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