Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

The EU cosmetics regulation in comparison to medicinal products: Evaluation of a risk-based approach ***

Damian Kaminski (Abschlußjahr: 2019)

Summary
Language: English    
Cosmetic and medicinal products share a long history with many similarities. Both types of products are shown to have healing and health-promoting properties. The external, cutaneous application of both cosmetics and medicine was, and continues to be, connected to physical strength and mental well-being. With the development of modern science and knowledge, cosmetics and medicines started to diverge; thus, different properties and perceptions have emerged.
Cosmetic science, unlike medicinal science, was often regarded as unscientific and inexplicable. This changed with progress in technology and industrialization. Subsequently, in the medicinal discipline of dermatology, the use of cosmetics has been approached in a scientific manner.
The additional knowledge gained helped to understand diseases, as well as their diagnosis and treatment. The field of dermatology has combined the science of cosmetics and medicine to develop hygienic therapies and meet sanitary demands. In the treatment of skin diseases, medicines are often used efficiently in combination with an appropriate cosmetic and hygienic "therapy".
The skin, the largest human organ protecting against external influences, serves as a natural physical and immunological barrier. Depending on the health and the condition of the skin of the individual, it may also be a vulnerable part of the body. Therefore, depending on the intended use, the risk-benefit ratio for a cosmetic product is calculated on a case-by-case basis.
After the industrial revolution at the end of the 19th century, it was possible to quickly develop and market medicinal and cosmetic products on an industrial scale. The growth in scientific knowledge and the scale of industrial production and affordable mass-market products led to the need for separate regulations and laws to combat the rising incidence of the misuse of products. Regulations for medicinal products were often introduced after catastrophes were caused by the uncontrolled and ill-conceived use of products and substances for medical purposes.
The aim of this Master thesis is to describe the legal requirements of cosmetics and pharmaceutical regulation, focusing on cosmetics regulation. The requirements of the European cosmetic product regulation will be examined, discussed, and evaluated, and the characteristics of medicinal and cosmetic products evaluated. In conclusion, whether cosmetic products in the European Union are regulated under a fair and balanced risk-benefit approach are assessed concerning safe use.
Pages: 72