Abstract

The common denominator between the commercial companies, wanting to optimise profits from existing and novel pharmaceuticals, and the national regulatory licensing authorities, is that both want to make safe, new drugs available to the patient population. For example, the EEC Rules which govern medicaments (1) state that the primary purpose of the comunity rules relating to the medicinal products is to safeguard public health whilst at the same time ensuring that the development of the pharmaceutical industry and trade in medicinal products will not be hindered.

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