Masterstudiengang "Drug Regulatory Affairs"
Master-Thesis
Marketing authorization of placebos legal requirements and requirements to the dossier in accordance to the German drug law
Dr. Uta Klöcker (Abschlußjahr: 2008)
Language: German
Regulatory, pseudo drugs containing auxiliary material or fillers but no pharmacological active substances are named (real/pure) placebos. In the regulatory field they are nearly exclusively known from its use as comparators in clinical trials. Real/pure placebos used in clinical everyday life are often not seen as compulsory approval medicinal products as they do not contain pharmacologically active ingredients.
In Germany, in accordance to the German drug law (AMG), proprietary medicinal products are permitted to be placed into circulation only if the responsible health authority has granted an approval. Main subject of the present master thesis was to clarify whether real/pure placebos are subject to the currently effective law for human medicinal products in Germany and whether they need a marketing authorization for this reason. In addition, particularities of the marketing authorization application of placebos are given.
Medicinal products and medical devices distinguish from other products for application on or in the human body by their medicinal purpose to cure, alleviate, prevent or diagnose diseases. Whereas medicinal products act pharmacologically, immunologically or metabolically medical devices have a mechanical, physical, chemical or physicochemical mode of functioning.
Real/pure placebos mostly used for diagnosis or abatement of psychogenic symptoms have a medicinal purpose. Their action is based on the placebo-effect which is attributed to psychological mechanisms and neurochemical procedures. In the neurochemical processes the release of body's own opiates and other neurotransmitter and their interaction with the respective receptors are involved. The placebo-effect results from the patient's belief in the treatment. Thus the psyche manipulates the body which reacts with a release of neurotransmitters and with a change of the regular chemical processes. Due to this metabolic action placebos for these special applications are assigned to medicinal products.
To place these placebos into circulation a marketing authorization application in the format of the Common Technical Document (CTD) is needed. As these placebos are medicinal products without an active ingredient in the marketing authorization application some particularities result especially in regard to the quality, safety and efficacy.
Pages: 51, Annexes: 1, pages: 4