The renewal process in the EU and the US for existing active substances requires advance planning and careful and attentive management. Following is practical advice to help you tackle the renewal of your plant protection active substance.
1. Form a Taskforce or Consortium
A major difference between the application for marketing authorization of a new active substance (AS) and that for renewal of an existing substance is that renewals are likely to involve more than one applicant and take the form of a joint submission. In fact, there is an expectation that stakeholders with an interest in the AS will reach agreement to cooperate in the re-approval process and submit a joint dossier.
For joint submissions to work efficiently, it is important to establish a task force or consortium of all companies that have an interest in an AS used in specific Plant Protection Product (PPPs). With many older chemicals out of patent, the list of interested companies could be large. By establishing a consortium, the division of the costs for dossier creation and submission can be shared within a clear legal framework. Once renewal is gained, all parties share the data, which can be used for the renewal of individual PPP registrations.
2. Plan Ahead and Start Early
From our experience, we know that you need to start well before the application date for an AS renewal. In the EU, where applications are required three years before the expiration date, we recommend starting the process at least two years before that – that is, five years before expiration. This gives sufficient time for several important activities, including to (see Figure 1):
- Assess data gaps: it is essential to review the data available for the AS against the current data requirements and guidance, to identify what data is missing or suboptimal. Past experience and learning from substances that have already been, or are being, evaluated as part of earlier Annex I Renewal (AIR) submissions can also be taken into account.
- Identify a costed plan for addressing gaps in data: once data gaps are established, the next step is creating a plan to address them. This plan should identify what studies could be defended and what new studies may need to be carried out. The challenge when consortia reach this stage is balancing the expenditure of new studies against the overall return from the AS. Having both regulatory and scientific expertise under one roof enhances decision-making and prioritization at this stage.
- Conduct studies: by starting two years before the application deadline for renewal, it is possible to conduct two seasons of field studies if required.
- Organize a pre-submission meeting with the Rapporteur Member State (RMS): this is the opportunity to have an open and frank discussion with the RMS about your AS, and the plans and strategy for renewal. It is important that particular areas of concern are discussed. Experience has shown these meetings are invaluable for both parties, with many questions answered.
- Prepare and submit the renewal application and updating statement: this should include a reference list detailing the new studies that are intended to be submitted in the supplementary renewal dossier.
- Prepare and submit the supplementary renewal dossier: the dossier should be written up to the appropriate standards and following the templates required. It is important to build a case that will resonate with regulatory reviewers, anticipating and answering their concerns. The dossier is prepared and submitted in CADDY format.
- Respond to RMS questions during their evaluation: the time for preparing responses is usually limited, and it is important to have a clear understanding what is being asked, so seek clarification if necessary. Try to answer as fully as possible.
- Comment on Renewal Assessment Report (RAR): it is important to be prepared to respond to the RARs when they are issued a year after dossier submission. Review them objectively and be prepared to defend studies and provide comprehensive answers to any questions.
Figure 1: The route through AS renewal
3. Work with a Partner
Given the complexity of managing these long-term, regulatory renewals and study programs, it can be of great added value to work with a partner who has experience in all the stages of the process outlined above. Ensure good communication and clear agreement of roles and responsibilities to optimize partnerships.
At Covance, we have independent regulatory consultants, scientific experts, experienced program managers and safety testing expertise, all under the same roof. Our global reach allows Covance to design studies that will not only satisfy EU regulatory authorities but also other global authorities. It is important to remember that once the AS has been re-authorized, the process of product renewal begins, following the procedures laid down in Article 43.
It is important to be bold but realistic during the renewal process. We suggest looking at your existing studies and plan a robust defense for them, while always having a contingency. Also, remember that this is an ongoing process. Renewal of approval is only a step towards meeting your commercial objectives, and the next stage of renewal of products, introduction of new products and extensions of use of existing products are just as important and require careful planning and management.
Everywhere you go, crop protection businesses face an ever-changing commercial and regulatory landscape. But with planning, partnership and a good CRO in place, you can supercharge your time-to-market.