Data Gap Analysis (DGA)
Our consultants will analyse the extend of data (i.e. studies undertaken by laboratories) that need to be generated in order to complete the dossier, depending on the objective pursued by the client. An estimation of the cost, timeline, and required samples will also be provided.
What is a Data Gap Analysis ?
A Data Gap Analysis (DGA) is the identification of the studies required to complete a registration dossier.
To obtain the approval of an active substance (a.s) or the authorization of a Plant Protection Product (PPP) the data requirements presented in Regulation (EU) 283/2013 (for active substance studies) and 284/2013 (for products studies) need to be met.
Three categories of data can be identified.
- Mandatory (always required, basic requirement)
- Triggered (required when certain conditions are met)
- Waived (possible to demonstrate that the data is not necessary)
A DGA is a strategic tool which will provide the list of study to be generated, their cost and generation timeline. In combination with the PRA, it will also estimate the risk for adverse results, the need for refinement studies and the likelihood of registration success.
Such information is key for strategic decision making regarding the active substance and Product an applicant want to invest in.
When is a DGA required ?
A DGA is required at the earliest stage of a registration project. It comes prior to the launching of a data package generation.
How does ENC perform a DGA ?
For each data requirement listed in EU Regulations (i.e. 283/2013 and 284/2013), ENC will check :
- if the data exists already in the applicant own data package, and is of sufficient quality;
- if unprotected data exists and remains of acceptable quality;
- if the data requirement is mandatory for the product and uses intended by the applicant.
Every active substance and PPP must be proven efficient but also safe for people’s health, animal’s health and the environment (risk assessment) before it reaches the EU market. To pass the risk assessment, the requirement for some additional studies can be triggered. These additional studies are identified with a Preliminary Risk Assessment (PRA).
EFSA guidances provides valuable information about some specific aspects of the EU dossiers preparation work. Those guidances are updated through time and new ones are published. It is important to carry out the DGA and PRA on the basis of the most recent guidances as they can influence the triggering of some study requirements. The DGA results are ordinarily presented in a table containing a row for each study theoretically needed.
What are the services provided by ENC ?
- Data gap identification to complete active substance and PPP data packages, depending on the registration objective pursued by the applicant.
- Monitoring of the tests in laboratory.
- Verification of Member States specific requirements (PPP Zonal applications).