EMA Lays Out Evaluation of Active Substances for Medicines

April 30, 2015

The European Medicines Agency is seeking feedback on the chemical structure and properties it considers in evaluating new active substance status.

To meet the assessment challenge, sponsors need to assess the molecular structure responsible for the substance’s physiological or pharmacological action. If the therapeutic moiety is considerably different from that of any other drug authorized in the EU as a medicinal product, then the substance can qualify for NAS status.

When a substance exposes the patient to the same therapeutic moiety as an existing approved active substance, the sponsor must provide additional evidence that the new substance differs significantly in properties with regard to safety and/or efficacy, the EMA says.

The reflection paper was accompanied by an updated guideline on the chemistry, manufacture and control of active substances. The new guideline combines both new and existing active substances in a single document, replacing two separate guidelines, but is otherwise unchanged.

The deadline for comments is July 24 for the reflection paper and Oct. 24 for the active substances guideline. View the reflection paper and updated guidance at www.fdanews.com/04-24-15-NASreflectionpaper.pdf and www.fdanews.com/04-24-15-chemistryguideline.pdf, respectively. — Jessica Grinspan