Standards Development

Scope

The purpose of this document is to provide the applicant submitting an animal disease in-vitro diagnostic reagent to control with the general input for the preparation of the control application file.

This document first lists the terms and definitions that are relevant to its reading and understanding and, where appropriate, used in other parts of the standard.

It describes the minimal administrative and technical information regarding the applicant, the manufacturer and the reagent required for the application file for initial control and for a batch to batch control respectively. It specifies, in particular, the validation parameters of the method using the reagent (objectives, methodology, criteria and results) according to international standards.

Purpose

This proposal is based on the French standard NF U47-301 “Animal health analysis methods - Presentation file for control of biological reagents used in the animal health sector” with the objective to define and harmonise a reference guide on diagnostic reagents control. It is the first of the three parts of the standard proposed on the control of reagents. This proposal aims at addressing the need to harmonise and facilitate, at European level and more widely, the control for marketing authorisation purpose of diagnostic reagents used in animal health (immunological and molecular methods). This is particularly important for diseases listed by European regulations for which health statuses are defined or for which sanitary controls on trade are required; statuses and controls being most often based on the results of approved diagnostic tests.

Up to now, there are no guidelines for implementing the control of animal health diagnostic reagents (performance criteria and experimental designs), neither at European nor at international level. Hence, there are as many different control procedures as different countries in Europe, which complicates the task of suppliers or manufacturers (at a cost) and users. The establishment of European standards, including the content of the files submitted for evaluation and of the reports, would therefore facilitate at term the mutual recognition of such reagents or even the centralisation of controls by appropriate reference laboratories, European Reference Laboratories (EURLs) for example.