Planning your Article 43 PPP Renewals: Data Gap Analysis
In a recent examination of Open EFSA Portal by Enviresearch, we identified there to be around 70+ active substances currently which have reached the EFSA Peer Review stage of the renewal procedure. Additionally, a review of the EU Pesticides Database showed there to have been 15 active substance renewals that have entered into force since the beginning of 2021. Whilst there have clearly been long-standing issues concerning capacity gaps for National Competent Authorities and EFSA in stewarding active substances through renewal procedures, our examination of the last 18 months indicates there is a steady stream of active substance renewal making their way through the system.
Of course, an active substance’s renewal of approval is not the end of the story for PPP authorisation holders, with the renewal date also triggering timelines to submit Article 43 applications for the renewal of authorisations for PPPs containing the active substance. The legal timeline for submission of Article 43 applications is short – within 3 months of the active substance renewal entering into force (unless other active substances are contained in the PPP and which are scheduled to be renewed within 12 months).
Clearly it is necessary that PPP authorisation holders plan their Article 43 applications well in advance of the active substance renewal date. A key early step in this planning process is to understand where and how the existing active substance and product (formulation) data packages previously used to support the current product authorisations need updating to comply with the current data requirements, guidance, and standards.
Performing a Data Gap Analysis (DGA) is the recognised approach within industry for identifying gaps in data packages and starting the process of planning strategies to address them. Whilst performing a DGA can look simple in theory, there can often be several nuances and complexities which come out in practice. For example, careful judgement may be needed when assessing if apparent data gaps truly are data gaps, and when considering how they can be most efficiently and cost-effectively addressed. From our experience, questions which commonly surface include:
- When can expert statements / reasoned cases be used to justify waiving the need to generate further data?
- When can scientific justifications be used to demonstrate existing data not formally compliant with current data requirements and guidance remains scientifically robust to support regulatory decisions?
- When can ‘Category 4’ data status be claimed to support postponement of Article 43 submission whilst further data is generated?