Globally probiotic products have shown exception growth driven by growing awareness of health benefits of microbiome-based products for multiple health, wellness, and therapeutic benefits. Biotics (including pro, pre and post), at the same time offer a unique challenge to regulatory professionals due to complex classification of biotics-based products due to specific strains used in the formulations, claims considered and quality standards accepted by different health authorities worldwide.
Classification of Probiotics
Probiotics can be classified as dietary supplements, medical devices, or pharmaceutical products / OTCs depending on their composition and claims. Further, each health authorities have their own positive and negative or approved strains list as well as limited predicate products already approved in the markets to use as a reference. Therefore, regulatory and commercial teams find it challenging to develop a synchronized go to market strategy for products.
Global Regulatory Requirements for Probiotics
Depending on the applicable classification of the final formulation, the data requirement from health authorities vary across countries. Most countries maintain a positive and negative list of strains. In case the strain is not already listed, strain listing becomes a mandatory step for probiotics. The authorities also evaluate whether the strain is novel or non-novel ingredients.
Probiotics registration and regulatory strategy varies significantly based on the current status, therefore significantly impacting the commercialization timelines and cost. Authorities also require maintenance of cell culture as per required standards. Further, based on the applicable classification (supplements, devices etc.) different quality standards are acceptable by agencies including GMP, FSSC 22000, ISO 13485 and others.
Potential Solutions for Harmonized Global Regulatory Strategy for Probiotics
A suitable solution for such challenges is to have a centralized source of regulations and guidance from different health authorities at one place, that includes approved list, positive / negative list of strains, pre-approved claims based on the product type (dietary supplements, medical devices, medicines etc.), acceptable quality standards such as (GMP, HCCAP, ISO 22000, ISO 13485 and others) in order to evaluate regulatory strategy for the products.
Further, since biotics may be classified differently across countries, regulatory professionals require to stay updated with new regulations, changes and announcements across categories such as dietary supplements, food, functional food, medical devices and medicines to ensure their global portfolio of biotic assets remain compliant.
Such approach helps in streamlining the strategy provide guidance to further work with R&D, Quality, Manufacturing and Leadership team to align the quality standards as per requirements, generate specific data set through tests that are widely accepted and invest in right quality management system that has global acceptability.
Conclusion
Probiotics, although marketed mainly as dietary supplements, are a complex category of products and require significant data to justify the safety and quality of products for human and animal consumption. The classification, listed strains, data required, cell culture requirements, quality standards acceptability vary significantly across countries resulting in complex go to market roadmap for manufacturers. Starting with a centralized approach for global markets leveraging latest AI based technologies can help streamline the process for the manufacturers.
At Artixio, we have built our regulatory intelligence and strategy platform with emphasis on probiotics, QuriousRI. Coupled with our regional regulatory teams, the platform provides access to global regulations for biotics, tracks changes and updates on a daily basis as well as helps perform quick compliance check of ingredients / strains, claims review, classification assessment and label review of continuous strategy development and compliance monitoring of biotic products.
Access QuriousRI here.
