Currently there are changes observed in the development of agrochemicals due to changing regulatory frameworks, data requirements and guidance globally; regulators and consumers are asking for safer products for man, animals and the environment, and this results in higher tier testing, additional testing requirements and higher tier risk assessments. Thus, within the EU there has been a change in the type of studies required in the development phase of the agrochemicals. For agrochemicals, the EU regulatory framework is given in Regulation 1107/2009. The aim of this regulation is to set all processes and procedures for the approval of active substances and the authorization of plant protection products in the EU. The specific data requirements are given in two Regulations: Regulations 283/2013 and 284/2013 and amendments for active substances and plant protection products, separately.
One of the new data requirements in the 283/2013 regulation is the performance of an in vitro metabolism study, in order to determine the relevance of the toxicological animal data and to guide in the interpretation of findings and in further definition of the testing strategy. A specific explanation should be given or further tests shall be carried out where a metabolite is detected in vitro in human material and not in tested animal species.
This type of study is routinely performed in the pharmaceutical setting, amongst others, to help drive species selection for the ensuing toxicology studies. The practical performance of such a study is therefore well established and has been a routine part of the Charles River offerings for many years.
Since this type of study is new to many agrochemical companies, it makes sense to reach out to a partner who has the expertise and experience to support you throughout. Charles River has performed many in vitro metabolism studies for both the pharmaceutical as well as the agrochemical industry and is well equipped for study execution, from incubations to identification of metabolites with a variety of MS techniques, both non-GLP as well as GLP. We have provided many reports as part of dossier submissions, and would welcome any further discussions on our capabilities or give advice on the what, how and why of in vitro metabolism studies.
Join Mira Wenker on April 24 for a webinar to learn how the new rules for in vitro data and its interpretation will affect the development and registration of your plant protection products. Register here