Bruneton C, Naboulet P, van der Heide B, Rey J L
Réseau Médicaments et Développement ReMeD, Paris, France.
Med Trop (Mars). 1997;57(4):375-9.
The quality of medicinal products marketed in developing countries has recently become the focus of lively debate and new interest. This report describes a survey conducted among officials from exporting and importing countries designed to evaluate the content and enforcement of current regulations. Resulting data indicated that, despite the high volume of trading in medicinal products between European and developing countries, regulations are poorly applied and many infractions occur. The most obvious abnormalities involve definition of market status. A list of banned is issued by the WHO but not by the European Economic Community. Regulations regarding generic products differ from one country to another and, since determination of the exact origin of a product may be difficult, compliance with good manufacturing practices is often unverifiable. A more cooperative attitude on the part of exporting countries and standardization of formalities on the part of importing countries will be necessary to stem the growing tendency to consider medicinal products as ordinary goods.
近期，发展中国家市场上药品的质量成为了激烈辩论和新关注焦点。本报告描述了一项针对进出口国官员开展的调查，旨在评估现行法规的内容及执行情况。结果数据表明，尽管欧洲与发展中国家之间药品贸易量巨大，但法规执行不力，违规现象频发。最明显的异常涉及市场地位的界定。世界卫生组织发布了一份禁用药品清单，而欧洲经济共同体却未发布。各国关于仿制药的法规各不相同，而且由于确定产品的确切来源可能困难，良好生产规范的遵守情况往往无法核实。出口国需持更合作的态度，进口国需规范手续，以遏制将药品视为普通商品的日益增长的趋势。
