Regulatory information – reflection on chemical structure and properties to be considered for the evaluation of new active substance status
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EMA releases draft reflection paper for public consultation
The European Medicines Agency (EMA) has released a draft reflection paper that outlines the chemical structure and properties criteria to be considered by EMA's Committee for Medicinal Products for Human Use (CHMP) for the evaluation of a new active substance status. The reflection paper also outlines the elements that applicants are required to include in their marketing authorisation applications in support of their new active substance status claim.
Stakeholders have until 24 July 2015 to provide their comments to qwp@ema.europa.eu using the form provided.
The draft reflection paper focuses on active substances that are structurally related to an already approved active substance (i.e., salt, ester, ether, isomer, mixture of isomers, complex or derivative of a chemical structure).
It does not cover biological and biotechnological active substances and active substances to be included in radiopharmaceutical medicines. These products will be addressed in a separate paper at a later stage.