Analogy
Compare the product with one already approved in a reference country.
Registration tools
Registration strategies
Select an approach suited to available resources, evidence and the regulatory framework of the target country.
A registration strategy is the overall approach used to evaluate and authorize a plant protection product. Depending on available resources, expertise and data, it may range from a basic route to an exhaustive assessment.
Equivalence
Demonstrate that the product is equivalent to one already registered locally.
Resource rationalization
Share data, extrapolate results or conduct joint reviews with other countries.
Local evaluation
Conduct a complete assessment using locally generated data and evaluations.
Other tools
Continue exploring the regulatory framework
01
Registration strategies
Select an approach suited to available resources, evidence and the regulatory framework of the target country.
Open this section02Registration process
From pre-registration through review, every step supports a structured assessment of the application.
Open this section03Data requirements & testing
Define the studies needed to demonstrate product efficacy and safety through internationally accepted protocols.
Open this section04Assessment methods
Apply procedures and models suited to each scientific component of the dossier.
Open this section05Risk mitigation
Define effective, practical and communicable measures to reduce health and environmental risks.
Open this section06Decision making
Connect risks, values, alternatives and management measures to reach a regulatory decision.
Open this section07Registration criteria
Verify that the product meets general protection goals and applicable scientific and legislative criteria.
Open this section08Assessment of alternatives
Compare available options when a product is highly hazardous or its risks are difficult to manage.
Open this section