Licensing of psychoactive drugs in the Netherlands.

The Dutch Board for the Evaluation of Medicines approves applications for a marketing authorization if on the basis of pharmaceutical, pharmacological--toxicological, and clinical data the benefit--risk balance is considered positive. In the Netherlands, almost 4000 drugs have a marketing authorization, 145 of these belonging to the psychotropic drugs. During the Board's existence the number of applications and the number of approvals for antipsychotics and antidepressants decreased, while an increasing amount of anxiolytics was applied for and approved. This phenomenon may reflect the prescribing behavior of doctors. The Board has on several occasions actively influenced the market situation of certain drugs, e.g., amphetamines have almost totally disappeared from the market since a strong restriction of the indications was imposed. A certain shift in the evaluation policy of the Board can be noticed in some respects, for instance, data on chronic use are no longer required for registration of hypnotics. The requirements for registration of antidepressants are less strict than in the past. The Board tries by its registration policy to be an objective interface between the drug-producing companies and the consumer, the patient, and seeks the highest standards possible in the drug market.