This is a CRN Associate Member Spotlight. Learn more: www.intertek.com/assuris/food/
Launching a functional ingredient globally is not for the faint of heart. Each jurisdiction brings its own regulatory hurdles, varying timelines, and intricate nuances. Intertek Assuris helps clients navigate this maze efficiently turning complex, multi-jurisdiction submissions into streamlined, strategic pathways. Moreover, Intertek's experts collaborate seamlessly with clients to craft and conduct clinical studies that align with regulatory standards.
Among key regulatory bodies, the United States New Dietary Ingredient Notification (NDIN) process often stands out as an entry point due to relatively short statutory review timelines and large market size, prompting many companies to begin in the U.S. before tackling other jurisdictions. Australia's Therapeutic Goods Administration (TGA) frequently follows, while the EU's stringent Novel Food authorization, overseen by the European Food Safety Authority (EFSA), ranks among the most challenging. However, there’s potentially a strategic advantage in entering the EU market before Australia. Securing a positive safety opinion from the European Food Safety Authority (EFSA) for use in supplements may open the door to fast-track approval in Australia.
For instance, such an EFSA opinion qualifies your application for Australia's fast-track IN1 pathway under the TGA’s Permissible Ingredients Determination. This slashes review times to roughly four months (compared to up to 14 months for the standard IN4 pathway) and cuts application fees in half. The TGA commonly recognizes EFSA safety opinions that encompass food supplement applications as “Comparable Overseas Body” (COB) reports.
Canada presents its own unique challenges. Natural Health Products (NHPs) require evaluation through Health Canada, with the “gold standard” being a randomized controlled human clinical trial demonstrating safety, efficacy, and supporting any claims.
By aligning regulatory strategy across jurisdictions, leveraging existing opinions, and anticipating data needs, Intertek Assuris propels clients from innovative concepts to successful multi-market launches swiftly and without costly setbacks.
Ready to move your ingredient across borders faster? Discover how Intertek Assuris can guide you through each step at www.intertek.com/assuris/food/