Critical Evaluation of the Toxicological Documents Produced for the Authorization of Drugs According to the Commission of the European Communities Directives

Abstract

The documents concerning the experimental safety evaluation of drugs are evaluated in France by an advisory board of the Ministry of Health which expresses an opinion on their accuracy, indispensable for the authorization of sale. The data reported here concern 95 documents examinated between 1978 and 1981. They are related:

• To the form of presentation of the documents: 14 main kinds of defects are pointed out (lack of justification of the protocols, inadequate experimental data, etc.).

• To the substance of the experiments: 21 main kinds of defects are emphasized (erroneous choice of the doses, poor clinical examination of the animals, etc.).

In conclusion, a real effort to obtain a large and constructive exchange of information between all the parties concerned, the manufacturers, the experts, the Ministries of Health, must be continued.