Europe – Shire Raises ‘Substantial Concerns’ About ICH Guidelines in Feedback to EMA

Shire has told the European Medicines Agency (EMA) it has “substantial concerns” about the impact of planned International Conference on Harmonisation (ICH) rules. The feedback relates to perceived discrepancies between the pharmaceutical product lifecycle management guideline and existing ICH documents.

ICH created Q12 to improve the management of post-approval changes to chemistry, manufacturing and controls. Shire and other commenters on the draft welcomed the guideline and opportunity to comment on it but brought up concerns about the compatibility of Q12 and other ICH guidelines.

“Shire notes significant discrepancies between this guideline and other related ICH guidelines,” the drugmaker wrote in feedback to EMA. “Given our substantial concerns regarding potential challenges to proper and timely adoption and implementation due to apparent misalignment, Shire urges the EMA and the ICH Expert Working Group to consider expanding, clarifying and specifying the linkage of this document to existing ICH guidelines.”…