ARTICLE FEED & ADDITIVE MAGAZINE May 2024 77 Animal health and feed additive products are crucial for maintaining the well-being and productivity of livestock and companion animals. By providing essential nutrients, managing health conditions, and optimising feed quality, these products help ensure the welfare of animals and the production of safe, high-quality food products. However, bringing animal pharmaceutical and feed additive products to market is a long and difficult process. A complex regulatory landscape exists with a wide range of requirements in quality, safety and efficacy/utility documentation and studies that must be met before a product may be approved. That landscape is further exacerbated by differences in requirements between regions and product categories. Successfully navigating this regulatory landscape can be a significant challenge for product developers, especially those new to the regulatory approval process. Misconceptions about timelines, product categories, and regulatory requirements can lead to lengthy delays and increased costs. For feed additives, the best-case scenario for generating data, submitting an application and gaining approval from the relevant regulatory authority after the review “Navigating the regulatory landscape for animal health and feed additive products can be a daunting task, but it is necessary to ensure quality, safety, and efficacy/utility. Although the road to regulatory approval can be difficult and costly, the benefits of bringing a new product to market are clear: happier, healthier, and safer animals.” THE ROAD TO REGULATORY APPROVAL OF ANIMAL NUTRITION AND HEALTH PRODUCTS Dr. Bill Zollers Head of Regulatory Affairs, Argenta Kansas Dr. Cornelia Hüttinger Head of Regulatory Affairs Argenta Munich Laura Payo Lewis Regulatory Affairs Director - Animal Nutrition Argenta Barcelona Prepared by Argenta with the participation of Bill Zollers, Cornelia Hüttinger and Laura Payo Lewis
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