Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Regulatory standards on clinical trials for medical devices and medicinal products in case of orthopedically used hyaluronic acid

Dr. Christine Binninger (Abschlußjahr: 2004)

Hyaluronic acid is commercially available on the European market for the indication of joint arthrosis, as either a medicinal product or as a medical device. The classification into one of the two product classes depends on the effect of the product on the human body. Marketing as a medicinal product implies pharmacological, metabolic or immunological activity. The mechanism of action stated by the manufacturer or the marketing authorisation holder has a decisive influence on this classification. If the molecular weight is under 1 million Da the pharmacological effect is thought to be dominant. Hyaluronic acid of higher molecular weight is said to act mainly by physical effects.

There is essentially no difference between the two classes of product with respect to safety in clinical studies. There are only minimal differences in the regulations on non-clinical studies or on the planning and performance of clinical studies.

Comparison of the studies performed with the medicinal product containing hyaluronic acid and with the medical device containing hyaluronic acid has shown that the implementation of these regulations has been practically identical.

Even though this thesis has been able to demonstrate that there are essentially no differences between the medicinal product and the medical device with respect to safety in clinical studies, the question remains open as to what extent it is reasonable to maintain the position on the market of the same active substance in two different ways.

In my opinion, the classification of a product as a medical device or as a medicinal product is solely depending on the subjective information provided by the manufacturer or marketing authorisation holder. This information on the dominant effect is the lens through which the scientific literature is seen. If it is planned to market the product as a medical device, proof enough will be found in the literature that the effects are only physical and the undeniable pharmacological properties are disparaged as side-effects. In contrast, if it is intended to market the product as a medicinal product, the literature for pharmacological effects is presented and the undeniable physical lubrication effect is disparaged as a side-effect.

My study of the literature has convinced me that the separation of hyaluronic acid preparations into two different groups with different molecular weights, resulting in different properties, is arbitrary.

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