By law, monographs for active substances cited in all marketing applications must be in compliance with a general monograph entitled Substances for Pharmaceutical Use and a chapter in the European Pharmacopoeia called Control of Impurities in Substances for Pharmaceutical Use. These cover a range of rules relating to levels, test methods etc.
"While recently-adopted monographs comply to a great extent with these requirements, there are some … old monographs which do not, according to the EC.
It points out that there is an unequivocal requirement for specific active substance monographs which correspond to the current scientific knowledge, including defined impurity profiles, as the globalisation of the sector means that regulators are confronted with many different sources.
This means there is a pressing need to revise these old monographs, a task that is already being undertaken by the European Pharmacopoeia. And as part of this effort, national licensing bodies are being asked to require applicants to bring their MA dossiers into line before an approval can be granted.
The measure will apply to all new applications, line extensions and variations (in which the manufacturer of the active substance changes), but not to already-marketed products.
More information on the proposal, put forward by the European Medicines Agency (EMEA), is available on the following website .
