On 19 December 2016, the European Medicines Agency (“EMA”) published an updated version of the EMA guidance document concerning post-authorisation procedural advice for users of ...24 January 2017
European Medicines Agency's draft strategy for antimicrobial monitoring
The European Surveillance of Veterinary Antimicrobial Consumption ("ESVAC") is a project established to collect information on how antimicrobial medicinal products are used in animals across the European Union ("EU") and European Economic Area ("EEA") Member States.
At the moment, ESVAC member states participate in the process on a voluntary base. However, the proposal for a new Regulation on veterinary medicinal products (VMPs) adopted by the European Commission in September 2014 introduces participation as a requirement. As stated in Article 54 of the final text of VMPs, European Union and European Economic Area member states will be required to collect and supply data on sales and use of antimicrobials to the European Medicines Agency (EMA).
Project ESVAC is a part of a strategy implemented for the period 2016-2020. One of the main ESVAC activities will therefore be to put in place the systems and procedures necessary to manage this anticipated future legal requirement for both national competent authorities and the EMA. It is anticipated that the Regulation will be adopted in 2017 to come into force two years later. However the exact date is yet to be determined.
The requirement for collection of data will include overall sales data, consumption data sorted by species and stratification of sales data. For the purpose of harmonising analysis result unification of measurement units is provided in the Draft. These data are essential to identify possible risk factors which could lead to the development and spread of antimicrobial resistance in animals.
Antimicrobial resistance ("AMR")
Antimicrobial resistance is an increasingly large problem, threatening effective prevention of infections caused bacteria, parasites and funghi.
To allow more accurate estimate of the exposure to antimicrobials by animal species and thus reinforcing accuracy of analysed data, ESVAC is establishing Defined Daily Doses for animals ("DDDvet") and Defined Course Doses for animals ("DCDvet").
Values of DDDvets and DCDvets will be published by EMA in the coming months.
The Draft Strategy
Data collected in accordance with the Draft Strategy is intended to provide a cue for development of EU legislation in formulating evidence-based policies to minimise the risks from use of antimicrobials.
With the provisions of the draft strategy EMA intends to harmonise data collection and analysis methodologies suggested in this draft guidance. Provided guidance will focus on collection of data per species, with a specific focus on the three major food-producing ones: pigs, poultry and cattle.
Until now, ESVAC has collected and published data on sales from up to 26 members of the European Economic Area ("EEA"), however the report intended to be published in 2016 will include data from 29 countries.
The deadline for submission of comments on the draft guidance is 30 June 2016. Comments to the proposed strategy should be sent via email using a specific template.
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