Scientific validation should not to be confused with a regulatory acceptance process. Before regulators can accept the use of a particular method in a regulatory context, for example in the area of safety assessment of chemicals, the method has to be:
The difference between scientific validation and regulatory acceptance process can be demonstrated with a simple example:
|In a nutshell: scientific validation is in most cases a necessary prerequisite for regulatory acceptance but successful validation per se is insufficient to guarantee regulatory acceptance.|
A number of regulatory bodies both at EU and international level assess methods for regulatory purposes in their respective fields such as for chemicals, pharmaceuticals and food and feed safety. In the EU, Directive 2010/63/EU brings regulators on board early on in the development of new alternative approaches, even before a formal validation starts. Each Member State is required to nominate a single point of contact for regulatory use of animals to speed up regulatory understanding, acceptance and uptake of new methods through the work of a PARERE Network .