VMP "non-GCP" studies
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For animal health, spontaneous AE reporting falls under Vol 9B and clinical study AE reporting falls under VICH GL9 (GCP), but what do marketing studies and field trials and non-GCP studies fall under? If nothing specific, does that mean that a company does not have to report those adverse events? If they report them under spontaneous rules, isn't that wrong?
Animal Health Committee
AHC reply: To the best of our knowledge the following applies for Adverse Events (AEs) reporting to the regulators in Europe:
1. Marketed products –AEs are reported via the normal PV system.
2. Pre-registered products – AEs reported according to the conditions of the trial permission. This can include GCP/GLP and non GCP studies. For GCP studies, reporting is also done according to GCP.
For non GCP studies, all AEs will be presented at least as part of the dossier. These AEs must have an assessment done according to the directive to establish whether the AEs are actually Adverse Reactions. For these AEs the dossier may be the first time that the regulator will be made aware of these AEs.
Other points for consideration:
3. For GCP studies where the comparator is registered. Any AE reporting for the comparator should be via the normal PV system and the IVP via GCP/trial permission.
4. Where the study is conducted in the EU however the comparator is not marketed in the EU but elsewhere, then the general advice would be to contact the global PV group to confirm where is was marketed and what are the reporting requirements for those countries.
A further consideration for GCP studies. If an animal is on an IVP treatment group and also on a concomitant veterinary medication; then if an adverse event occurs, should an AE report be recorded against the concomitant medication?
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Please note that our committee activities relate to the promotion of quality systems relating to the conduct of pre-clinical and clinical research and development studies associated with the marketing of medicinal products for use in animals.
As such, we are unable to answer the technical aspects of this question, but recommend that you contact either the Food Standards Agency (FCA)/Veterinary Medicines Directorate (VMD) if based in the UK, or alternatively your national food safety organisation for a more informed response.