[The problem of selection of monographs]

The problem of selecting the monographs to be inserted in a pharmacopoeia does not actually exist on a national, but only on an international scale, as was realized during the compilation of the European Pharmacopoeia. The problems encountered at that time are discussed here. The first section of this paper describes the various principles, ideas and interpretations that are at the root of the divergent opinions expressed by the delegations at Strasbourg in facing this problem each time it comes up for discussion. These divergent opinions are centered mainly on the following: -developments and progress in the pharmaceutical profession; -differences existing among various national legislations; -basic concepts concerning pharmacopoeias; -more or less broad interpretations of the obligations set down in the Convention and in the General Rules of the European Pharmacopoeia; that is, in essence, the principle of the possibility of opposing the monographs and the application of this principle. On the basis of these considerations, the author advances, and tries to justify, the criteria that, according to him, should be adopted in order to arrive at common rules. The criteria are the following: -therapeutic interest, provided it is medically confirmed; -importance of usage, under the four specific aspects to be considered. On the subject of a new substance: -necessity that the product be produced by several manufacturers; there are three cases, where the rules to be observed have not been obeyed by all concerned. -obligation that the product be marketed in bulk, except in cases specifically established. While making this report, the author intends to emphasize the fact that a great effort is needed in order to narrow the gap separating certain points of view.