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Regulatory News | 05 March 2015 | By Michael Mezher
As part of its efforts to combat antimicrobial resistance (AMR), the European Medicines Agency (EMA) has issued two draft guidelines related to the use of antimicrobial agents in veterinary medicinal products.
Resistance to antimicrobials is not a new phenomenon. Scientists have observed AMR as far back as the late 1930s, following the discovery and mass use of sulfanilamide. Alexander Fleming, the scientist who discovered penicillin, warned of the risk of AMR in his 1945 Nobel lecture.
Scientists’ concerns about AMR have risen in recent years, fueled by the rise of treatment-resistant bacteria and the sharp decline in antibiotic development in recent decades.
EMA announced that it is holding a public consultation on two draft guidelines regarding veterinary use of antimicrobials.
The first guideline is intended to give advice to companies looking to apply for marketing authorization for antimicrobial products for veterinary use. The guideline asks that companies assess the risk of AMR stemming from a products’ use, and details the methodology and data requirements related to AMR companies will need to present when applying for approval. One of the concerns EMA hopes to address in the guideline is the risk of AMR being transmitted to humans through their use in livestock.
The second guideline is a revision to the Committee for Medicinal Products for Veterinary Use’s (CVMP) existing guideline on demonstrating the efficacy of antimicrobial products for veterinary use. The revisions aim to provide recommendations to companies on designing studies to demonstrate the therapeutic efficacy of their antimicrobial veterinary products. The guideline also instructs companies to study co- and cross-resistance in relation to their products.
EMA is asking interested parties to submit their comments on the guidelines by 31 August 2015 and 31 May 2015, respectively.
EMA is not the only agency taking action to help combat AMR.
In January, three EU agencies—EMA, the European Centre for Disease Prevention and Control (ECDC) and the European Food Safety Authority (EFSA)—released the first of a series of joint reports on the use of antimicrobials. The reports are intended to aid the European Commission’s action plan to head off the threat of AMR.
The first report sought to investigate the “possible relationships between the consumption of antimicrobial agents and the occurrence of [AMR] in humans and food-producing animals.” The report found large variations in how antimicrobials were used in various countries in the EU.
Tags: Antimicrobial resistance, AMR, Veterinary