Active substance data
A PPP dossier is based on three pillars
Active substance data
Access to the a.s. data package
Technical equivalence
A source of technical a.s.
equivalent to the EU reference source
What is the active substance data ?
“Active substance data” is referring to a package that includes all the studies performed with the active substance and its relevant metabolites. It is core to the dossier in support of the authorization of the active substance by the European Commission.
What is the role of the active substance data ?
The European Commission evaluates every active substance and check that it satisfies high environmental and human safety standards before it reaches the market.
Active substance data will provide :
- information on the hazard of the active substance (or its metabolites) to human health and to the environment (cut-off criteria) and
- endpoints required for the risk assessment.
The data requirements are listed in Regulation (EU) n° 283/2013. Access to a given active substance data package is required to obtain registration of a PPP containing this active substance.
Main applicant or generic applicant? Approval of a new active substance or renewal of an existing active substance ?
The main applicant is actively developing and defending the EU approval of the active substance. He generates the approval/renewal dossier to the EU authorities. After evaluation, the EU publishes a list which details all active substance studies in support of the EU approval. Some of the studies receive data protection, which provides temporary commercial advantages.
The generic applicant follow the lead of the main applicant and matches the list of protected studies. This can be done by :
- obtaining a letter of access;
- performing compensation study;
- waving the study by demonstrating that it is not necessary;
- demonstrating that the data protection has expired.
| Main Applicant | Generic Applicant | |
|---|---|---|
| Strategy | Active participation to the approval/renewal of the active substance | Preparation of a compensation dossier to match the studies relied upon in the main applicant dossier |
| New active substance approval requirements | – Data package on active substance – Data package on 1 PPP – 1 use (or more) – Risk assessment – Registration of a reference source of active substance | – Access to protected active substance data: * Obtaining a letter of access; * Performing compensation study; * Waving the study by demonstrating that it is not necessary. * Demonstrating that the data protection has expired. >>> Compensation dossier & Data Matching Table – Data package on 1 PPP – 1 use (or more) – Equivalence of the source of active substance (Technical equivalence dossier) – Risk assessment |
| Renewal of existing active substance requirements | – Updated active substance package – Updated PPP package – Updated risk assessment (new endpoints, new EU guidances) | – Access to the updated active substance package: * Obtaining a letter of access; * Performing compensation study; * Waving the study by demonstrating that it is not necessary; * Demonstrating that the data protection has expired. >>> Compensation dossier & Data Matching Table – Updated PPP package – Updated risk assessment (new endpoints, new EU guidances) – Source of active substance compliant with the new specifications of the reference source |
| Submission timing | The application for renewal needs to be submitted at least 3 years before the expiry of the approval. The dossier itself is submitted 2,5 years before that date. | Within 3 months after active substance renewal these documents need to be submitted: – Demonstration of access to the active substance data – Technical equivalence dossier – PPP dossier (Zonal applications) |
The data requirements are set out in Regulations 283/2013/EU for active substance and 284/2013/EU for PPP.
Theoretically, the all process from submission to (re-)approval of the active substance takes 2,5 to 3,5 years.