Regulatory intelligence & pharmacovigilance updates, mapped to your role.

Stakeholders, including those involved in labeling and signal management, should consider the published comments to align future processes with the regulatory expectations detailed in the draft ICH E22 guideline.

MAHs should review the updated DRGD to understand new processing timelines for variation submissions and assess how the reliance mechanism can be leveraged for faster safety updates. Adjust internal timelines and processes for post-marketing variation submissions accordingly.

Review updated PMDE Program procedures on CDA-AMC website and assess impact on current post-market surveillance activities in Canada.