ARTICLE 78 FEED & ADDITIVE MAGAZINE May 2024 process could be 3-4 years while, for health products, this may take 6-8 years. In either case, however, the data generation and approval process can be delayed by years if a comprehensive and complete dossier is not submitted or if studies must be redone. To mitigate the risk of delay and its fiscal impact, complying with the relevant guidelines and regulations is critical from the outset of product development. In this article, we shed light on the common challenges that occur on the journey to regulatory approval for animal health and feed additive products and demonstrate how planning and partnerships can help you navigate this complex landscape. Specifically, we will cover: • Keeping up to date with current regulatory guidance • Product formulation challenges • Manufacturing and site qualification • Safety and residue testing and setting tolerance levels • Study site identification and patient recruitment for animal health products • Compiling data packages for the US and Europe Through understanding the common challenges and strategies for navigating the regulatory landscape, developers can enhance their chances of success and bring products to market more efficiently. DEMYSTIFYING COMMON REGULATORY CHALLENGES FOR ANIMAL NUTRITION AND HEALTH PRODUCTS There are several key bottlenecks and challenges in regulatory approval that product developers should consider as they approach quality, safety, and efficacy/utility testing. Each of these challenges has the potential to delay timelines and add significant costs during the product development and submission process. KEEPING UP TO DATE WITH CURRENT REGULATORY GUIDANCE Regulations and guidelines evolve as regulatory authorities keep up with new safety data, novel techniques, and government policies. As a result, the regulatory landscape can shift substantially during the years required for product development, potentially leading to unforeseen changes in requirements. But there are steps developers can take to help mitigate risks. For example, in the US, developers are encouraged to work with the Center for Veterinary Medicine (CVM) to agree on the pivotal clinical study protocol prior to conducting the study. This allows product developers to mitigate the risk of regulatory changes affecting their clinical study. It’s important to note that the health and feed additive spaces are regulated separately, with feed additive guidance updated more frequently in the European Union — typically every two to three years. Accordingly, product developers need to stay informed about potential regulatory changes on the horizon. By closely monitoring regulatory updates, developers can stay ahead of a curve and ensure their planned product testing and data dossier meet the latest requirements. A major challenge in product development is demonstrating the safety and efficacy/utility of a product, while ensuring that the final formulation is well characterised. Generating the necessary data to support the dossier is often a time-consuming and expensive process, especially for complex formulations requiring multiple iterations in clinical development. As a result, the complexity of the formulation and robust data needed to support regulatory approval can create significant challenges for product developers. The risk of delays can be reduced with careful planning around the regulatory requirements regarding formulation and investing early in its development. MANUFACTURING AND SITE QUALIFICATION Good Manufacturing Practice (GMP) standards are essential for regulatory approval of animal health products. CVM/European Medicines Agency conduct regular inspections to ensure cGMP compliance. While GMP requirements apply to all manufacturers, there are more obligations for organisations importing investigational veterinary medicinal products manufactured outside of the re-
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