EMA advises EU pharma companies on how to test if an active substance is truly new
Also releases revised detailed guidance on the chemistry of new active substances
Guidance on assessing whether a medicine contains a new active substance has been released by the European Medicines Agency (EMA). Such an official recognition can be especially valuable, with EMA gatekeeping whether a substance’s chemical structure clearly differs from those of other authorised substances.
The advice says that if a chemically active substance is structurally related as a salt, ester, ether, isomer, mixture of isomers, complex or derivative of active substances previously approved in the EU, it should still be assessed. It can be certified as a new substance if it does not share 'the same therapeutic moiety at the site of the biological activity as the already approved active substance and…differs significantly in properties with regard to safety and/or efficacy'.
The guidance advises in detail on how to qualify a new active substance as a salt, ester, ether, isomer, mixture of isomers, complex or derivative.
Eligibility to EMA market approval procedures based on the claim that the medicine contains a new active substance must be dissociated from the assessment of scientific data submitted during evaluation of the marketing authorisation application, added the guidance.
Meanwhile, EMA has also released revised detailed guidance on the chemistry of new active substances, replacing advice released in 1996. It stipulates the type of information required for the manufacture and control of active substances (existing or new chemical entities). The guidance clarifies the differences in requirements for new or existing active substances. It is not applicable to herbal, biological, biotechnological products, radiopharmaceuticals and radiolabelled products.
