Veteriner ilaçlarının insan yemeğinde yer alan kalıntılarının güvenliği değerlendiriliyor (İng)


New EMA draft Guidance-Studies to evaluate the safety of residues of veterinary drugs in human food: Genotoxicity testing 

EMA has published draft guideline- VICH topic GL23(R): Studies to evaluate the safety of residues of veterinary drugs in human food: Genotoxicity testing- Draft revision at step 9; for consultation at step 4. The period for comment ends in March 2013. 

There have been differences in the genotoxicity testing requirements of the EU, Japan and the USA for establishing the safety of veterinary drug residues in human food. This guideline is one of a series of VICH guidelines developed to facilitate the mutual acceptance of safety data necessary for the establishment of ADIs for veterinary drug residues in human food by the relevant regulatory authorities. It should be read in conjunction with the guideline on the overall strategy for the evaluation of veterinary drug residues in human food (see VICH GL33). This VICH guideline was developed after consideration of the existing ICH guidelines for pharmaceuticals for human use: “Genotoxicity: A Standard Battery of Genotoxicity Testing of Pharmaceuticals” and “Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals”. Account was also taken of OECD Guidelines for Testing of Chemicals and of national/regional guidelines and the current practices for evaluating the safety of veterinary drug residues in human food in the EU, Japan, the USA, Australia, New Zealand, and Canada. 

This guideline recommends a Standard Battery of Tests that can be used for the evaluation of the genotoxicity of veterinary drugs. In most cases, the results will give a clear indication of whether or not the test material is genotoxic. However, the Standard Battery of Tests is not appropriate for certain classes of veterinary drugs. For instance, some antimicrobials may be toxic to the tester strains used in the test for gene mutation in bacteria. The guideline advises on amendments to the basic battery of tests that are needed for the testing of such drugs. In some instances the results of the Standard or amended Battery of Tests may be unclear or equivocal, so advice is given on the assessment and interpretation of results. Additional testing may be required in some instances, e.g. substances showing potential aneugenic and/or germ cell effects. 

In most cases, it is the parent drug substance that is tested, although in some cases it may be necessary to also test one or more of the major metabolites that occur as residues in food. Instances when the need to test a metabolite may be required include situations in which the metabolite has structural alerts that are not present in the molecular structure of the parent drug and when the residues in food are mostly in the form of a metabolite that has a molecular structure that is fundamentally different from that of the parent drug. Salts, esters, conjugates and bound residues are usually assumed to have similar genotoxic properties to the parent drug, unless the converse can be demonstrated.

 The objective of this guideline is to ensure international harmonisation of genotoxicity testing.