ABSTRACT
Peptides produced either from natural sources or synthesized can adhere to specific country food regulations. There are several clinical studies, which confirm that peptide produced synthetically can cure specific diseases as a drug and it can be approved by Food and Drug Administration of Unites States and European Medicines Agency. In countries like USA, Japan and Europe, so far 70 peptide drugs were approved for its use, around 150 drugs were in active clinical developmental stage and 260 had been already tested successfully in clinical trials. Totally out of 372 new molecular entity (NME), the US-FDA has granted marketing authorization to around 18 peptides over the last decade. Every bioactive peptide were not deemed to be foods, most of them can be placed under the category of natural health foods. Now-a-days, there is a tremendous growth for use of drugs from non-pharmaceutical sources. The Health Canada regulates the manufacturing and selling of natural health products under Food and Drug Act, whereas Food & Drug Administration, USA is responsible for regulating the production and sale of such products as dietary supplements in USA. Therefore, this chapter will address the global regulations of peptides to be used as a natural health foods and drugs depending upon its source of production, intended use etc.
