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The Importance of Clinical Trials
The authorisation of medicinal products requires clinical trials without which therapeutic progress would be impossible. Although the safety and efficacy of new medicinal substances are first tested in vitro (the analytical test) and in tests with animals (the pharmacological-toxicological test), the therapeutic efficacy of a drug is only finally established by a trial in humans (the clinical trial).
Clinical trials are usually also conducted for authorisation of well-established medicines - that is, the authorisation of generic medicinal products - for which an abridged authorisation procedure is available if the generic is 'essentially similar' to the well-established reference drug. In a judgement made on 3rd December 1998 (the 'Generics judgement'), the European Court of Justice (ECJ) held, among other things, that a medicinal product is essentially similar to an original medicinal product when (1): |
