Fed Regist. 1999 Mar 9;64(45):11376-7.
The Food and Drug Administration (FDA) is announcing the establishment of a public docket for the submission and public availability of information concerning the implementation of the Mutual Recognition Agreement (MRA) between the United States and the European Community (EC) in the areas of pharmaceutical good manufacturing practices (GMP's) and medical devices. FDA is also establishing contact points for information covering particular subjects under the MRA implementation, and the agency is making appropriate information available on the FDA web site.
美国食品药品监督管理局(FDA)宣布设立一个公共文档,用于提交和公开有关美国与欧洲共同体(EC)在药品生产质量管理规范(GMP)和医疗器械领域实施相互认可协议(MRA)的信息。FDA还将设立关于MRA实施中特定主题信息的联络点,并且该机构正在FDA网站上提供相关的适当信息。