Preparing Modular Labeling Information for Pharmaceuticals and Radiopharmaceuticals

Abstract

Drug labeling for new chemical entities should provide adequate information, supported by scientific facts from the drug development program, so that the health authority, physician, pharmacist, and consumer understand how to use a drug and the results to expect. This paper is intended to assist in the preparation of modular labeling information for new chemical entities that can be used for worldwide submission. It is based on current United States Food and Drug Administration (FDA), European Union (EU), and Canadian Health Protection Branch (HPB) regulations or directives. The current lack of international standards on format and content of labeling information precludes one set of labeling information worldwide, and makes the modular labeling information approach workable for the pharmaceutical industry.