Regulators

MAHs should prepare for enhanced regulatory collaboration, including potential joint oversight activities and reduced market friction between the UK and US due to closer alignment in regulatory decisions.

Review the PSUSA documents for calcifediol and ensure alignment with any PRAC recommendations if applicable.

Check stock for the affected batches of Ponlimsi (Denosumab) 60mg solution for injection and follow the instructions in the MHRA notice.

Marketing authorisation holders should prepare to update their COVID-19 vaccines to target the XFG variant for the upcoming campaign; monitor for further regulatory guidance and prepare for potential strain change submissions.

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.

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