Regulation and Product Development

Depending on intended use of a probiotic (drug vs. dietary supplement), regulatory requirements differ greatly. If a probiotic is intended for use as a drug, then it must undergo the regulatory process as a drug, which is similar to that of any new therapeutic agent. Despite the promising evidence, the role of probiotics in human health as well as the safety of their application should be further investigated as the current knowledge of the characteristics that are necessary for their functionality in the gut is not complete. The factors that must be addressed in evaluating the effectiveness of the incorporation of the probiotic strains into such products are, besides safety, the compatibility of the product with the microorganism and the maintenance of its viability through food processing, packaging, and storage conditions. The product’s pH for instance is a significant factor determining the incorporated probiotic’s survival and growth, and this is one of the reasons why soft cheeses seem to have a number of advantages over yoghurt as delivery systems for viable probiotics to the gastrointestinal tract. Current technological innovations provide ways to overcome probiotic stability and viability issues offering new options for their incorporation in new media and subsequent satisfaction of the increasing consumer demand. The safety profile of a potential probiotic strain is of critical importance in the selection process. This testing should include the determination of strain resistance to a wide variety of common classes of antibiotics such as tetracyclines, quinolones and macrolides and subsequent confirmation of non-transmission of drug resistance genes or virulence plasmids. Evaluation should also take the end-product formulation into consideration because this can induce adverse effects in some subjects or negate the positive effects altogether. A better understanding of the potential mechanisms whereby probiotic organisms might cause adverse effects will help to develop effective assays that predict which strains might not be suitable for use in probiotic products.

  • Trial design
  • Pathogen detection
  • Food packing, quality assurance and safety
  • Investment models and current market opportunities
  • Strain identification, designation and safety
  • Establishment of standards and guidelines
  • Health claims and labelling
  • GLP and GMP perspective
  • Bringing live bacterial products to market
  • Regulating claims of efficacy
  • Necessary quality control
  • Postmarket surveillance
  • Clinical Studies
  • Optimising delivery and survival of strains at site of action
  • Probiotics product production & development
  • Current market trends and probiotics production
  • Probiotics Market- Regulations, business and health perspectives

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