Registration and Submission
Most governments across the world require the registration of new pesticide active ingredients, new products containing an existing or new crop protection chemical pesticide and new uses of existing products. Variations in specific registration processes exist with crop protection substancespesticides often governed by multiple regulations. All regulators, however, require clearly presented regulatory arguments based on robust scientific and technical data.
In the EU/EEA, registration of active substances and plant protection products are governed by Regulation (EC) No 1107/2009.
In Japan, the Agricultural Chemicals Control Act sets out the process of the crop protection chemicals registration.
In the USA, pesticide crop protection chemical registration falls under two main legislations FIFRA (Federal Insecticide, Fungicide, and Rodenticide Act) and FFDCA (Federal Food, Drug, and Cosmetic Act) with additional amendments from the Food Quality Protection Act and the PRIA (Pesticide Registration Improvement Act).
- Global and regional knowledge and insight provide by specialists crop regulatory scientists
- Established success in active ingredient and product registration and submission to US and EU, Japan & US regulators
- Experience in registration and submission covering a wide range of crop protection productspesticides, including conventional chemicals , biopesticidesand biopesticides. and biocides
How to get your crop protection product registration and submission right
There is a lot to think when registering a crop production product. What specific regulations are relevant to your active substance or products? What endpoints do you need for the regulator? What data do you have and what do you still need? How do you fill those data gaps? What data waivers could you ask for? Have you got enough environmental risk assessment information? What is the process for dossier submission? What are your obligations during evaluation?
Ensuring crop protection product registration and submission success
Covance has a diverse regulatory science team coming from industry, regulatory agencies, consultancies and research institutes. That gives you a wealth of expertise to call on. By leveraging expert insight and practical experience you will be guided through crop protection product registration and submission in an efficient, cost-effective and stress-free manner.
Covance can provide the following range of services:
- applications for data waivers
- negotiations for data access
- program management of a full suite of safety and environmental studies
- dossier compilation and submission
Support that goes beyond registration and submission
Our dedicated regulatory scientists provide ongoing monitoring and support for each crop protection product submission. All the administrative and technical aspects of registration and submission are tightly managed. This ensures timely responses to regulatory milestones and regulator questions. Once an evaluation begins, our regulatory scientists provide expert data-driven advocacy for your product.