ICH Q9 to Become an Annex to the EU GMP Guide after Being Passed

GMP News No. 565

GMP News
30 May 2005

ICH Q9 to Become an Annex to the EU GMP Guide after Being Passed

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."

The top conference ICH Q9 "Quality Risk Management", presented by the University of Heidelberg and supported by BApÖD and ECA, with 2 members of the ICH Q9 Expert Working Group as well as speakers from FDA and EMEA takes place in Heidelberg, Germany, on 21 June 2005. Only few places are left. You can find the programme at:


Compiled by:
Oliver Schmidt


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