CURRENT REGULATORY (DRAFT) GUIDANCE ON CHIRAL MEDICINAL PRODUCTS - CANADA, EEC, JAPAN, UNITED-STATES

The rapid development of stereospecific analytical, synthetic, and pre parative methods has profoundly changed the prospects for development and application of chiral medicinal products. This has induced regulat ory agencies, e.g., in Canada, the EEC, Japan, and the United States, to prepare guidance on this subject. The present draft documents are d iscussed, with emphasis on the two most important cases: (1) New racem ates: How many extra requirements are justified? (2) Development of a single enantiomer from an approved racemate: how few are acceptable? A t the moment the opportunities for early harmonisation are favourable and the formulation of one international guidance document seems feasi ble. (C) 1994 Wiley-Liss, Inc.