To obtain it, the holder must demonstrate with a technical dossier the quality of the product (manufacture under good practices, stability, controls on each batch), its safety and its efficacy for the indications it applies for, usually with clinical trial data.
Registration is not granted to a molecule in the abstract but to a specific product: a manufacturer, a formulation, a presentation and a set of indications. That is why two products with the same active ingredient can have different regulatory situations.
Research materials (RUO) have no sanitary registration as a medicine. That is precisely the legal boundary that separates a laboratory reagent from a product for use in people.
When you read that a peptide “is approved”, it is worth asking: which product, by which authority and for which indication? The approval of a medicine does not extend to other products with the same molecule.
Related terms
Learn it in depth at the Peptide University
- Special populations and class warnings · Module 10
- Thymosins and thymic extracts · Module 12
- Hierarchy of evidence and development phases · Module 13
- Complementary monographs (16–20) · Module 14
Definition for educational and scientific purposes. It is not medical advice or a recommendation for use. NeoPeptidos products are sold labelled for research use only (RUO).