Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Die Entwicklung unterschiedlicher Rechtsvorschriften und deren Überwachung im Bereich der Sicherheit von Arzneimitteln und Medizinprodukten in Deutschland (Pharmako- und Medizinproduktevigilanz)

Sigrun Adrian (Abschlußjahr: 2010)

Language: German

This master thesis compares the influence of recognised risks of medicinal and medical products on the reglementation.
First a short overview about human history in treatment of patients with medicaments and with medical products is given.
Already in the early history of mankind people became attentive on the problems of undesirable effects of many remedial plants which are often also toxic.
In the antique some famous scholars taught her pupils as patients are to be treated with poison and remedial plants.
At that time it was known that many patients died because of wrong dosage.
Some antique doctors published their knowledge also for her contemporaries and the future generations.
Medical products caused fewer problems in the former history of mankind, because they were simply constructed and their effects and side effects were transparent.
The development chemically defined medicament made a standardization of the active substances possible.
This seemed to be a big progress in safety of the treated patients compared with the problematic remedial plants, which contain depending on external influences fluctuating amounts of active substances.
Therefore, a reliable dosage was difficult, particularly if the herbal active substances are toxic.
This support of chemicals completely changed, after several medicament disasters became known in the last century.
In the USA the Massengill disaster took place in 1937.
Elixir of Sulfanilamide, containing the poisonous solvent diethylene glycol, killed 107 persons, many of whom were children, dramatizing the need to establish drug safety before marketing and to enact the pending food and drug law.
In 1938 the Federal Food, Drug, and Cosmetic Act was passed by US Congress.

In 1961 Thalidomide, a new sleeping pill was found to have caused birth defects in thousands of babies born in western Europe especially in Germany.
Because of this disaster politicians arouse public support for stronger drug regulation.
In 1961 the AMG passed to ensure greater drug safety. For the first time, drug manufacturers were required to register their products.

The rapid development in science caused an increase of complicated medical devices like X-ray devices and heart pacemakers in hospitals and it caused more safety risks for patients because the clinic staff were not trained sufficiently.
This vigilance problem caused in 1985 a new regulation for active medical devices in Germany called MedGV.
Since 1990 the medical device legislation was given by the EU. The Medical Devices Directives 90/385/EWG, 93/42/EWG and 98/79/EWG were intended to harmonise the laws relating to medical devices within the EU.
In Germany they were transformed in national law (MPG) in 1995 as well as later changes of the Directives were.
The great increase of medicinal products and medical devices on the market caused a lot of safety risks for patients. The vigilance systems, or the surveillance of the safety of medicinal or medical products during their life on the market, have been extensively improved by a number of new regulations in the last decades. They are governed by regulations of the EU which are either directly binding or have to be transposed into national legislation.

The purpose of this thesis is to describe the changes from the beginning of the German Law for drugs and medical devices caused by safety concerns up till now.
It compares changes in the regulations of medicinal and medical products.
The former differences between the regulation of drugs and medical devices seem to decrease, as can be seen by the introduction of risk management systems in drug law or the approval of clinical studies for medical devices by the BfArM from 21.03.2010.

Pages: 60