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The trend toward uniformity of drug registration procedures due to imminent European Economic Community globalization has encouraged pharmaceutical companies to conduct studies on a worldwide basis. This standardization of methods will facilitate the "poolability" of efficacy and safety data generated by these international studies into a common database. With the internationalization of the pharmaceutical marketplace, physicians in industry may be required to collect and interpret such reports from all over the globe. The globalization of the pharmaceutical industry will thus broaden the opportunities for physician involvement in safety detection.

Within the European Community (EC) countries the national pharmaceutical regulatory systems work with varying degrees of efficiency and scientific sophistication. At the Community level the objective of mutual recognition has failed to be realized. To achieve for one registration application within the EC, timely and simultaneous marketing approvals throughout the member states will require changes to the present regulatory procedures or the single market concept for pharmaceuticals will not be realized. To have the greatest chances for success we should move cautiously, identifying and correcting deficiencies in the present procedures, which are known from experience, rather than abandoning such hard won knowledge for a new system with all its attendant potential unknowns and uncertainty. The free movement of drugs within the Internal European market will be a reality. The question remaining is at what price will it be achieved? It is vital to the European economy and consumer, as well as to the innovative pharmaceutical industry, that Europe does not exchange its present competitive edge in the time to develop and register new drugs for a costly drug lag. The experiment must equally succeed as a torch showing the way forward not only for an enlarging European Community, but also to the ever increasing interest in global harmonization of drug regulation.

The European Community must become a fully integrated market by 1992. The differing national requirements for pharmaceutical product registration constituted a barrier, unresolved by the creation of a nonmandatory process of mutual recognition of pharmaceutical licences. Interested parties have been asked to recommend measures to abolish the remaining barriers. The principle sought is that a single authorisation shall afford simultaneous approvals in all member states. Considerable debate has taken place but there is no clear concensus. Recommendations include mandatory mutual recognition, a central FDAlike European Agency and a combination of both. A tripartite solution is recommended. This is a sharing of responsibility between the National Agencies and a central European body. A small European Secretariat would coordinate activities and, using expert consultants, hear and resolve appeals. The National Agencies would share the licence application assessments and the CPMP would be responsible for, among other things, the education standards of Agency personnel.

This study outlines the attempts of four states (Louisiana, Kansas, Wisconsin, and Michigan) to restrict anorectic prescriptions. The actions in these four states exemplify the various mechanisms used in regulating anorectics, ranging from educational efforts to legislative enactments. We examine the evidence used in promulgating these policies and review some of the current literature on the safety and efficacy of anorectics. Despite the existence of evidence demonstrating the safety and efficacy of anorectics, the states seem to be moving toward more severe restrictions, in contrast to the federal regulatory agencies.

Between 1982 and 1983, the Commission on Approval for Marketing Medications of the French government made 76 negative decisions based on problems with clinical trials. In 21 instances, the reasons for a temporary negative decision could be resolved from data already on hand or readily available. More serious problems resulted in requests for new studies having better controls, better management of ancillary therapy, more participants, or lasting longer. Indications that denial of the application is likely or outright refusals to grant approval were based on failure to demonstrate efficacy and concerns about toxicity. Analysis of the reasons for negative decisions can ameliorate the clinical trials submitted in support of an application for marketing approval. Improving the design and conduct of clinical trials based on correcting the defects discussed here would benefit the sciences of drug development, regulation, and patient care.

To determine the impact of FDA advisory committee review on the approval time of new drug applications (NDAs) approved during the five-year period 1983 through 1987, we compared NDA phase lengths of reviewed new chemical entities (NCEs) with those that were not reviewed and examined the elapsed time from final committee recommendation for approval to NDA approval. Of the 95 drugs approved during the study period that met the Center for the Study of Drug Development's definition of an NCE, 40 (42%) were submitted for review--mean NDA phase length was 36.9 months versus 32.4 months for unreviewed drugs. Reviewed drugs in the neuropharmacologic division had a longer NDA phase, while those in the metabolic/endocrine and oncology/radiopharmaceutical divisions had shorter NDA phases, than unreviewed drugs in those divisions. For NCEs grouped by therapeutic rating, reviewed drugs in each category had longer NDA phases than unreviewed drugs; the difference was largest for 1-B rated drugs. The elapsed time from committee recommendation for approval to NDA approval as a percent of the total NDA phase was greatest for drugs submitted by the metabolic/endocrine division (83.0% of NDA phase) and for drugs rated 1-A (63.2%). Results indicate that advisory committee review is associated with a small overall delay in NDA approval when compared with the regulatory fate of drugs not submitted for review.

This article looks at the history and development of drug regulation in Australia, concentrating on the changes that have occurred in the last few years. It touches briefly on the system by which many drugs are subsidized and examines the way in which a de facto "restricted" list became less restricted. It deals with clinical trial approval procedures as these have changed markedly and turns to consider advertising and promotion of drugs. In concluding, it discusses the advantages and some of the shortcomings of the system.

South Africa has a population of approximately 30 million people. The country has a mixture of advanced industrial and rural economies, but the medicine control system is consistent with similar systems established in the major industrial countries of Western Europe and North America. Because most of South Africa's population lives in conditions more closely akin to the developing world than to the Western nations, it is important to examine whether the country is optimally served by this drug regulation model and to define critically the strengths and limitations of the established system. The conclusions might be relevant for other countries at a comparable stage of development.