Objective: The aim of this study was to review the regulatory framework for probiotics at a global level. Material and Methods: An overview of existing regulations for probiotic products in the USA, Canada, Japan, Australia and New Zealand and the EU was made. Accordingly, legal regulations and legal texts concerning the categories to which probiotic products belong were analyzed. Publications and guidelines of regulatory agencies of individual countries were also reviewed. The results are presented as an overview of the possibilities of categorization and basic requirements for the development and labeling of probiotics according to the countries, ie the European Union. Results: Probiotics are the subject of research, innovative product design, marketing, regulatory oversight, consumer interest and use by healthcare professionals. It would be useful for all those involved in these aspects to clearly understand the criteria needed to use the word "probiotic" responsibly. But it is difficult to make proper use of that term in the absence of a single definition and categorization. Regulatory frameworks, although different in countries around the world, influence research approaches, communication strategies, product manufacturing, and product labels. Depending on the product category in which the probiotics are placed, the applicable legislation applies to them. It is universal that, unlike medicinal products, dietary supplements and food must meet much less stringent regulatory criteria. Conclusion: There are no globally harmonized regulatory requirements for probiotics and the term probiotic is sometimes improperly used. The development of guidelines and a harmonized framework for probiotics, including general specifications and considerations, is necessary to ensure and maintain high-quality probiotic products and could simplify industry requirements, reduce consumer confusion and improve the scientific framework for the research community.