Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Aesthetic indications: How to bring aesthetic medicinal products to the market?

Barbara Petri (Abschlußjahr: 2015)

Summary
Language: English
The sector of aesthetic interventions is rapidly growing worldwide. This means also that there is a growing group of people being exposed. Those users start from the assumption that they are acting in a well-­‐regulated market and are not aware of the dangers involved. There are comprehensive reasons to improve the appearance, especially to reduce blemishes and disfiguring elements. If medicinal products are supposed to be used for this purpose, they have to show the correction or modification of a physiological function, e.g. hair growth, or have to be intended to improve the condition “important psychological impact” that is caused by the underlying physical flaw. This generic term was investigated and suggestions were made how to approach the proof of the existence and improvement of said impact. The general challenge that in aesthetic interventions physically healthy people are exposed to potentially painful intended effects and adverse reactions has to be addressed in providing a maximum of safety measures during the development and the post marketing phase. All these measure could be laid down in guidance documents issued by the health authorities. The US example shows that tackling the regulation of aesthetic medicinal products is also possible without the theoretical construct of an illness.
Pages: 40