Pesticide dossiers, an opportunity for medical writers

Abstract

Pesticides, also known as crop protection products, are approved for sale through a process similar to that for authorising human medicines. For example, the toxicology data submitted are nearly identical to the nonclinical data generated for a drug, and the environmental risk assessment is similar in many ways to the risk assessment for human medicines. Consequently, an experienced medical writer could prepare a pesticide dossier. This article briefly describes the regulatory requirements for preparing a pesticide dossier and where to find detailed guidance and examples to help a medical writer with this type of regulatory document.