03 October, 2018

3 steps to achieve successful active substance renewal

By Gary Dean

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The renewal process in the EU and the US for existing Active substances requires advance planning and careful and attentive management. Understand the key steps in the process by reading the final blog in the series.

Tractors harvesting a field of wheat1. 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.

Learn more about “Preserving lifecycles: renewing existing plant protection active substances” by downloading our informative e-book.

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 expiry date, we recommend starting the process at least two years before that – that is, five years before expiry. 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 are 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.

 C319 [Blog] Preserving lifecycles figure 1-1

Figure 1

3. Take home messages

The renewal process in the EU for existing ASs requires careful planning and attentive management. Four key take home messages are:

  • Start early and plan ahead: do not leave planning for your renewal to the last minute. You need to start planning at least five years before the AS expiry date to give you time to establish, if necessary, a task force or consortium and agree your strategy, budget working practices and study program for the renewal process.
  • Communicate clearly and work collaboratively with others: effective working partnerships with other stakeholders, such as task force members, consultants and CROs, requires good communication and clear agreement of roles and responsibilities. Engage with the renewing authority early to establish possible issues and scope.
  • Be bold but realistic: review the data for your AS and characterize data gaps comprehensively; however, do not be afraid to look at your existing studies and plan a robust defense of them, while always having a contingency.
  • Remember 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.

Learn more about “Preserving lifecycles: renewing existing plant protection active substances” by downloading our informative e-book.

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About the author

Gary started his career at Envigo in 1985 and is currently the Business Lead Consultant for Crop Protection. As business lead, Gary provides regulatory advice to Envigo’s customers to ensure their programs of work and applications for active substance approval or product registration meet the highest possible scientific and regulatory standards set by global authorities.

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Category // Crop protection, plant protection products, crop regulation, Gary Dean