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
DOI: 10.3109/10715762.2012.756138 75
Conceptual evolution of cell signaling
It was very rare we would find somebody in the Wellderly who was obese or smoked still, very rare
Which, when used correctly, makes your face look fresher, brighter, smoother and more radiant over time
