The lifecycle management section of the newest working draft of ICH’s Q11 guideline on drug substance development and manufacturing provides allowance for applicants to include change management proposals in their original submissions.
The issue of post-approval changes has been a challenging one for the Q11 Expert Working Group (EWG) to address, given the differing legislative/regulatory frameworks in the regions that need to be accommodated. The ICH mandate proscribes against including in its guidelines anything that would require a legal change to implement.
However, the rapporteur for Q11, Brian Withers (Abbott UK), reported at the CASSS/FDA Well-Characterized Biotechnology Pharmaceutical (WCBP) conference in Washington, D.C. on January 12 that the three regions had agreed to include a provision in the guideline that applicants could make proposals in the original submission for how they would “make specific changes to their product in a post-approval setting.”
Noting that providing flexibility within the lifecycle section to manage change was high on the industry wish-list, Withers pointed to the revision as “some way along the route that we were, from the industry point of view certainly, looking for.” The guideline, he noted, also includes the ICH Q8R provision that moving within the approved design space does not require a regulatory approval.
[More from rapporteur Withers on the EWG progress on Q11 is provided for subscribers here. For further coverage of the ICH Q11 effort, see IPQ “In the News” July 9 companion stories on the guideline’s structure and content and handling of starting materials, respectively. Non-subscribers may purchase this story for $95 by contacting Peter Blachly (firstname.lastname@example.org). For IPQ subscription information, click here.]