(1997; 248 pages) [French]
3.3 Products containing new chemical entities
Considerably more extensive information is required to support a marketing application for a new drug substance in order to provide assurance of efficacy and safety as well as of quality. In particular, detailed accounts are required of:
(a) chemistry (structure, physical properties, synthesis, specification, impurities, stability characteristics);
(b) pharmacological properties (in animals, in humans);
(c) toxicological data (short and long-term studies in animals, including carcinogenicity studies);
(d) reproductive and teratological studies in animals;
(e) clinical studies.
Small regulatory authorities need to adopt caution in licensing newly developed products because they are likely not to possess the capacity to undertake the multidisciplinary assessment applied to them within large, highly evolved authorities, or to monitor their performance in use through postmarketing surveillance.
In general, a small authority is best advised to wait until this information has been generated and assessed elsewhere before authorizing such a product for use.
In the case of products intended exclusively for tropical parasitic diseases, much of this evidence may need to be built up in countries with limited resources. The expertise of the World Health Organization is at hand to offer advice in these circumstances. Once a decision is taken to authorize such a product for general use, the regulatory authority and the manufacturer share a responsibility to ensure that a monitoring mechanism is put in place to detect unanticipated reactions. A mutually acceptable plan for postmarketing surveillance should be settled in advance and included in the product licence as a condition of approval.