ARTICLE FEED & ADDITIVE MAGAZINE May 2024 79 gion. These requirements, if not considered early, can lead to delays and additional costs. Furthermore, in the US there are additional requirements for importing investigational medicinal or feed additive products. For instance, importing medicinal products requires appropriate notification to the FDA of the Investigational New Animal Drug holder. SAFETY AND RESIDUE TESTING AND SETTING TOLERANCE LEVELS Residue and tolerance testing are essential components of the regulatory approval process for veterinary products affecting food-producing animals. Designed to demonstrate safety of your product for human consumption, these studies are required to establish tolerance levels for compound residues in food products. However, conducting residue and tolerance testing poses unique regulatory challenges for product developers. One challenge is generating new data to establish tolerance levels, which has to be done even if another sponsor has previously provided human food tolerance data for the same compound. Without their own raw data, or if it is not sufficient to ‘reset or confirm the tolerance’, the regulatory approval process can be delayed. In both the US and EU, human food safety testing may require radiolabelled studies to track the depletion of compounds through the animal’s body and into food products. However, performing these studies can be difficult as they rely on specialist equipment, expertise, and study sites. Product developers must take a proactive, regulatory-focussed approach to food residue and tolerance testing to minimise delays and ensure their studies are compliant with regulatory requirements. STUDY SITE IDENTIFICATION AND PATIENT RECRUITMENT FOR ANIMAL HEALTH PRODUCTS Clinical field studies are critical components of the product development process for medicinal products, but they have the potential to cause major delays. While good communication with the regulatory authorities is essential for planning and approving protocols in line with current guidance, logistical issues associated with setting up clinical field studies often prove to be the most common challenges. For example, identifying appropriate study sites and recruiting patients can be significant bottlenecks, particularly where patients are limited in your target indication. Furthermore, clinical field study data are essential for regulatory submissions, and can take weeks or months to complete. Delays at the outset of these studies can significantly impact the approval timeline, leading to lost resources or increased costs. Product developers can ensure a smoother path to
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