Zdrowie i gospodarka · 6.09.2005

International Conference on Harmonisation; Draft Guidance on M5 Data Elements and Standards for Drug Dictionaries; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled "M5 Data Elements and Standards for Drug Dictionaries." The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance describes the data elements and standards that ICH recommends be made available to interested parties to assist in the development and maintenance of drug dictionaries. The draft guidance is intended to facilitate the exchange and practical use of medicinal product information at the international level, such as with postmarketing safety reporting.