ISSUE FOCUS FEED & ADDITIVE MAGAZINE February 2025 51 where deviations are and are not appropriate to ensure alignment. PREPARING FOR THE CHANGES: KEY STRATEGIES FOR REGULATORY SUCCESS While the new guidance updates may present challenges, with the right approach, applicants can avoid missteps and maximize the chance of a successful application. Proactive Planning By preparing early for the upcoming changes and aligning studies with the draft guidance as soon as possible, developers can reduce the risk of needing to revisit or repeat studies further down the line, preventing unnecessary and costly later-stage disruptions. Leveraging Regulatory Expertise Experienced regulatory partners can offer valuable support, providing in-depth knowledge of the current regulatory landscape to help applicants interpret and apply the guidance effectively. By engaging a regulatory partner early in the process, applicants can ensure that the right types of data are being generated and compiled into a robust dossier, reducing the risks of clock-stops and streamlining the path to approval. Staying Informed Tracking the draft guidance as it evolves and moves towards implementation is essential, as it will help developers to better understand exactly what will change and have more time to plan for and accommodate those changes. SHAPING THE FUTURE OF FEED AND FOOD ADDITIVES The draft guidance represents a significant change for microorganism feed additive developers. While these changes open the door to new opportunities, they also bring new challenges and complexities. With the final guidance expected to be published in June 2025, industry stakeholders must act decisively to align to the updates. By proactively planning, leveraging the expertise of regulatory partners, and keeping track of the guidance as it evolves, developers can ensure compliance and avoid unnecessary delays to their applications for a smoother journey to market. To stay updated on the latest regulatory developments and gain insights into how the changes could impact your program, subscribe to our newsletter. Be the first to receive industry news, expert insights, and invitations to upcoming events, including Argenta’s exclusive webinar following EFSA’s final microorganism guidance release. References 1https://www.efsa.europa.eu/en/topics/topic/feed-additives About Andrew Bell Andrew Bell, Regulatory Affairs Manager at Argenta Barcelona, with over a decade of experience in analytical microbiology and regulatory affairs, he supports clients from project inception to EU authorisation for feed additives and novel foods. About Flavia De Marta Flavia De Marta, Business Development Manager at Argenta Barcelona, brings extensive experience guiding organisations through the EU approval process for feed additives. She has been a key liaison with EFSA and the European Commission (EC) in previous roles in the animal health and nutrition industry.
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