ARTICLE 80 FEED & ADDITIVE MAGAZINE May 2024 regulatory approval by building strong relationships with regulatory authorities and other clinical stakeholders to conduct thorough logistical planning around site identification and patient recruitment. COMPILING DATA PACKAGES FOR THE US AND EUROPE While the US and EU share a common goal of ensuring robust quality, safety, and efficacy/utility data, they have different standards and requirements for submitting data. Consequently, submitting the same data package to regulatory authorities in both regions is insufficient. While there may be some overlap in the data required by each authority, developers must carefully plan their study designs and data dossier compilations to meet the unique submission and assessment requirements of each region for their chosen product category. To optimise cost-effectiveness and efficiency in the submission process to authorities in multiple regions, product developers should thoroughly assess testing requirements. For example, it may be that there are simple measures that can be taken to ensure one study adheres to both US and EU requirements rather than having to complete two studies. By proactively addressing these requirements, developers can minimise delays and ensure that each dossier aligns with the submission guidelines of the respective authority. ROADMAP TO REGULATORY SUCCESS In the complex regulatory environment of animal health and feed additive products, there is potential for delay and increased costs at every step of the development and approval process. Product developers can help mitigate these risks for their organisations by preparing for the regulatory submission journey as early as possible in the development cycle. A REGULATORY ROADMAP TO INFORM YOUR DEVELOPMENT PLAN Mapping the route from product categorisation to regulatory approval can help inform the product development plan, establishing relevant milestones, timelines, and potential costs. Having these identified early can help your organisation manage expectations with stakeholders and secure sufficient funding prior to embarking on the long and costly product development and approval journey. Furthermore, comparing existing data with an up-to-date regulatory roadmap may reveal if it can be used for dossier submission. Some early testing, particularly around product composition and quality, may already meet existing guidelines and not require additional testing. Careful monitoring of the regulatory horizon for potential changes to guidelines and regulations should be factored into the regulatory roadmap to avoid unnecessary repetition of costly tests during product development. BUILD RELATIONSHIPS WITH CRO/CDMOs WITH REGULATORY EXPERTISE Delays in the regulatory approval process can have significant repercussions, potentially leading to increased development costs and underserving both consumers and animals. To mitigate risk of delay, product developers must cultivate beneficial relationships with a range of stakeholders, including the regulatory authorities, manufacturers, clinicians, and regulatory experts to ensure that their roadmap supports the product development plan. Partnering with an animal health CRO/CDMO with deep regulatory expertise can help you curate your regulatory roadmap and development plans as you progress through the product development cycle. Such partners can perform a gap analysis to identify what data are missing and which tests must be conducted, and also provide clearer visibility of the project’s costs and timings. By maintaining the regulatory roadmap/gap analysis as a living document, the development plan can be updated as gaps are filled, or as timelines or costs change. Animal health CRO/CDMOs with regulatory experts can also help mitigate some of the general challenges faced by product developers from the outset. Many of the processes performed in early development such as formulation and product release profiling generate data that can be used in the regulatory
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