The European Medicines Agency (EMA) is looking for feedback on a draft reflection paper that lays out its criteria for determining whether biological substances are considered new active substances (NAS). The document walks sponsors through the factors to consider when determining whether a NAS claim meets regulatory requirements.
On 18 November, European regulators asked stakeholders for comments on its recently published reflection paper on NAS. Generally, for “well-characterized and highly purified active substances” the main component tends to serve as the basis for the substantiation of a NAS claim. In such cases, it is normally sufficient to compare the substance’s basic structural element to substantiate the claim…
