The QMN Weekly Bulletin

FDA Releases Draft Guidance on Annex to ICH Q8 Guideline

Feb. 8, 2008

More clarity on how drug manufacturers may change production processes within a preapproved range without having to submit postapproval supplements is detailed in the FDA’s new draft guidance on the International Conference on Harmonisation (ICH) Q8 Guideline.

The FDA previously released the guideline as a potential path for firms to gain regulatory flexibility for manufacturing operations.

The new draft “is intended to show how concepts and tools (e.g., design space) outlined in ICH Q8 could be put into practice by the applicant for all dosage forms,” the FDA says. The annex originally was issued by the ICH in November 2007.

The draft, “Q8(R1) Pharmaceutical Development Revision 1,” was published in the Jan. 10 Federal Register. Comments are due by April 9. More information can be accessed at