[International harmonization of regular requirements for the registration of drugs: necessity, frena limitations].
Considering the necessity of internationalisation, the Pharmaceutical Industry fears the regulatory variations that may result from national evolutions, parallel or divergent, which sometimes impose on it some repeated works, hence causing an undesirable extension of development duration and also higher costs. Therefore it is quite evident to that Industry that a worldwide harmonization is necessary. For the whole collectivity, such an harmonization allows a better utilization of manpower, of animal experimentation, and also of the material means available for the new pharmaceutical products development. The strong interest showed by the Pharmaceutical industry in France for the International regulatory harmonization, confirms that this Profession has effectively taken into account the worldwide dimension for the medicinal products of the year 2000.
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Santini
D006801:Humans; D007880:Legislation, Drug; D009626:Terminology as Topic
L'harmonisation internationale des exigences réglementaires en matière d'enregistrement des médicaments: nécessité, freins, limites.