EMA Finalizes Guideline on Evaluating New and Existing Active Chemical Substances

December 1, 2016

The European Medicines Agency adopted a final guideline setting out the information required for the evaluation of active chemical substances used in drug products.

Information submitted should include proprietary and nonproprietary names; structural and molecular formulas, as well as the relative molecular mass; and a schematic representation of the manufacturing process, along with a narrative describing the production procedure.

The guideline does not apply to herbal, biological, biotechnological products, radiopharmaceuticals and radiolabeled products, and does not apply to contents of submissions during the clinical research stages of drug development. Nevertheless, the EMA said, the principles in the guideline should be considered during investigational stages.

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