title: International regulatory aspects of clinical periodontal research.
abstract: The Food and Drug Administration (FDA) was the pioneer regulatory agency to set standards for clinical studies aimed at approval of new drugs. For years the FDA's rules represented the most thorough, stringent, and consistent policy. Now most other developed countries have comparable requirements for the conduct of clinical trials. The European Community (EC). Canadian, and Japanese regulations are most important for United States (US) scientists attempting to globalize their research. Regulations in Eastern Europe, some Asian countries, and Latin America are of growing importance. The Pacific-Rim appears to be the fastest growing pharmaceutical market in the next decade. Currently, the EC and Japan's Good Clinical Practice (GCP) regulations are more detailed than those of the US. Moreover, the World Health Organization recently published GCP recommendations similar to the EC requirements. Well-designed and well-controlled studies done in the EC, US, and other developed countries are generally accepted throughout the world. Japan and some other countries require studies in local patients. American scientists cannot expect to conduct studies in other countries as principal investigators, but many are associated with national clinicians. Mutual recognition of marketing approvals is the ultimate goal for the globalization of drug research. While it is the objective of the Scheme for the Mutual Recognition of Evaluation Reports on Pharmaceutical Products and the EC Decentralized Procedure, it is not apparent when the FDA will totally accept another regulatory body's approval decision. The International Conference on Harmonization involves the EC, Japan, and the US. This most important series of meetings will finally align the major countries more closely in regulating clinical studies and the production of safe, effective, and quality products, especially in these times of worldwide economic considerations and health care reform. It is imperative that US dental scientists become more familiar with pertinent regulations in leading foreign countries.
authors.affiliation: Cooley Consulting, Inc., Wyoming, Ohio, USA.
authors.forename: W E
authors.initials: WE
authors.lastname: Cooley
authors.forename: A W
authors.initials: AW
authors.lastname: Castellion
mesh_terms: D001208:Asia; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence* / Q000592:standards; D004341:Drug Evaluation / Q000331:legislation & jurisprudence / Q000592:standards; D004335:Drug and Narcotic Control / Q000331:legislation & jurisprudence* / Q000458:organization & administration; D005060:Europe; D005062:European Union; D006801:Humans; D007391:International Cooperation; D007843:Latin America; D010510:Periodontal Diseases / Q000628:therapy*; D010517:Periodontics / Q000331:legislation & jurisprudence* / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration; D014944:World Health Organization