EMA on Active Substances

[membership level=”0,4″][The content continues for paid members only.] Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership] EMA released a guideline describing the type of information required in a marketing authorization regarding the manufacture and control of active substances used in a medicinal product. It revises an earlier guideline to cover both new and existing active substances and clarifies the differences in requirements. The guideline is applicable to active substances that have been developed following a “traditional” or an “enhanced” approach as described in ICH Q8-11, or a combination of these. It is not applicable to herbal, biological/biotechnological products, and radiopharmaceuticals.
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