title: Regulation and abuse liability testing of medicines in Europe beyond 1992.
abstract: The procedures for approving medicines have been progressively harmonized within the European Community. The authorization of medicinal products beyond 1992 will be based on a more centralized procedure, with important safeguards to ensure that there is no dilution of strict standards of quality, safety, and efficacy. Although some efforts have been attempted to coordinate the procedures for approving medicines with Japan and the United States, some important problems still remain. An example of this lack of coordination is the lack of agreement about applying abuse liability testing to psychotropic drugs. In the United States, abuse liability data are routinely used for scheduling and labeling new drugs under the supervision of the Food and Drug Administration (FDA). This agency has codified the requirements for clinical studies of potential abuse of psychotropic drugs and requires pharmaceutical sponsors to submit specific data. However, requirements within the European Community in this matter are minimal. Clinical trials on subjective effects, drug discrimination or drug preference are not requested. This situation demands more scientific interchange between officials and scientists from the FDA and their counterparts from Europe. The Committee for Proprietary Medicinal Products (CPMP) must play a major role in this coordination and interchange.
authors.affiliation: Ministry of Health and Consumer Affairs, Madrid, Spain.
authors.forename: F
authors.initials: F
authors.lastname: García Alonso
mesh_terms: D004341:Drug Evaluation / Q000639:trends; D004335:Drug and Narcotic Control / Q000331:legislation & jurisprudence*; D005060:Europe; D005544:Forecasting; D006801:Humans; D011619:Psychotropic Drugs; D012307:Risk Factors; D019966:Substance-Related Disorders / Q000517:prevention & control*
chemical_list: D011619:Psychotropic Drugs