EMEA has now published how the ICH Guideline ICH Q9 "Quality Risk
Management" should be implemented within the European legislation.
First of all, EMEA emphasises that no new requirements or expectations
are intended to be introduced with ICH Q9. The Agency rather expects that
this document is implemented together with existing quality-related
regulations.
As soon as the ICH Q9 Guideline has been passed, it will become an Annex
to the EU GMP Guide. EMEA's announcement continues:
"..., however it should be noted that it may be
applied to all aspects of pharmaceutical Quality."
For this reason, the guideline will also have consequences for EMEA's
Quality Guidelines published by CHMP and CVMP, among others on the
registration procedure.
Even if the scope of ICH Q9 is primarily orientated
towards medicinal products for human use, EMEA
stresses the fact that an application in the context of medicinal products
for veterinary use would be useful. EMEA writes here: "Public comments on this point
would be particularly welcome."
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