Regulation and boundary between cosmetic, medical device and medicine In Europe, topical peptides fall under three distinct regulatory frameworks according to their claim and mechanism: Cosmetic (EC Regulation 1223/2009) Surface cutaneous action, beauty and hygiene claims No therapeutic claim authorised Product information file (PIF), safety evaluation Examples: Matrixyl, Argireline, Pal-GHK in anti-ageing serums Medical device (EU Regulation 2017/745) Main physical/mechanical action, medical claim Classes I, IIa, IIb, III according to risk CE marking mandatory, notified bodies for class IIa+ Example: GHK-Cu dressings for wound healing Medicine (Directive 2001/83/EC) Explicit therapeutic claim, pharmacological action MA mandatory (EMA or national agencies), phase I-III clinical trials Example: Afamelanotide for erythropoietic protoporphyria (MA 2014) This segmentation has direct implications for research : a molecule can change regulatory status according to its final formulation and claims
Rajendiran, K., et al
or (2) Highly Integrated DSNPs, which are able to provide their enrollees with flexible supplemental benefits, which must not duplicate Medicaid benefits, but may help to bridge the gap between Medicare-covered and Medicaid-covered services (CMS, 2016b)
Growth hormonereleasing hormone effects on brain -aminobutyric acid levels in mild cognitive impairment and healthy aging
