Avrupa İlaç Ajansı (EMA), Antimikrobiyal Direnç Risk Değerlendirmesi Kılavuzu için Kavram Raporu yayımladı (İng)
EMA issues a Concept paper for a guideline on antimicrobial resistance risk assessment
CVMP has issued a concept paper as it intends to draft a guideline on antimicrobial-resistance risk assessment to be applied for all classes of antimicrobial agents. The guideline would apply to all new applications for marketing authorisations including extensions and some variations (where changed doses or new indications are claimed).
Antimicrobial resistance (AMR) is an important issue to be addressed in applications for marketing authorisations of veterinary medicinal products (VMP). When related to target animal pathogens and possible lack of efficacy, resistance related issues are discussed in the clinical part of the dossier. In addition, risks to public health linked to use of VMP are to be considered and this will include not only risks from antimicrobial residues but also risks from resistant bacteria in food as detailed in Annex 1 to 17 Directive 2001/82/EC as amended. Human beings might be exposed to resistant bacteria either by direct contact with animals or indirectly via food or the surrounding environment. Of the possible exposure scenarios, foodborne exposure (consumers’safety aspects) is the most important to consider due to the high number of people concerned.
The CVMP intends drafting a guideline on antimicrobial resistance risk assessment to be applied for all classes of antimicrobial agents. The guideline would apply to all new applications for marketing authorisations including extensions and some variations (where changed doses or new indications are claimed). It might also apply in case of reassessment of existing marketing authorisation for antimicrobial agents, pending outcome of the revision of legislation. The guideline will provide a model for a structured risk assessment based on data requested according to GL27 and other relevant sources.