Abstract
Classification and labeling of medicines for use during pregnancy is a subject of constant debate, particularly within regulatory agencies. This report summarizes the outcome of a discussion of a DIA workshop held in 1998 in Munich, Germany. The following issues were on the table: 1. To what extent and how should the information derived from animal studies be presented in the Summary of Product Characteristics? 2. What are the requests for toxicity studies to include women of childbearing potential in clinical trials? 3. What is sufficient human experience and how can it be achieved? and 4. New proposals of the text for the label from the Committee for Proprietary Medicinal Products (CPMP), the regulatory authority in Europe.
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