The primary aim of pharmaceutical legislation in the drug regulatory environment is to protect public health. Therefore sufficient documentation to prove appropriate quality, safety and efficacy has to be submitted to the competent authorities for any medicinal product under the scope of a marketing authorization process.

According to European legislation as given in Directive 2001/83/EC, toxicological testing of a new substance is required prior to its use in humans.

Within the framework of the present master thesis the regulatory toxicology will be discussed regarding the need for animal testing of new drug substances prior to human use and possibly available alternative methods therefore.

Before data from a newly developed alternative method can be used successfully in a marketing authorization process of a new drug, the validity of the method has to be proven and the regulatory acceptance must be given.

Despite the fact that there is a broad variety of activities underway to develop and establish alternative methods for animal testing, only few methods are already validated and accepted by regulatory authorities. In many areas of regulatory toxicology there are still no alternative methods available which would allow to reduce the number of needed animals and thus reduce the time and costs connected with a pre-clinical development program.

The future trend in regulatory toxicology will surely go towards the establishment of further test methods not needing living animals. However, due to the fact that many promising methods are still in an early stage of development and due to the required time for validation and regulatory acceptance of alternative methods, cost and time intensive animal testing strategies will not become redundant in the near future.

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