Issue Date: September 6, 2005
Issued by: Center for Drug Evaluation and Research
Topic(s): ICH-Multidisciplinary
Status: Draft
M5International Conference on Harmonisation; Draft Guidance on M5 Data Elements and Standards for Drug Dictionaries
It is desirable for regulators and pharmaceutical industry to engage in an intensive information exchange during the drug development phase, the drug evaluation and approval phase and the post-authorization phase. The standardization of medicinal product information is regarded as one of the key elements of this information flow.
Download the Guidance Document
