Country Requirement

Regulatory compliance workflows involving the Dengue Tetravalent Vaccine outside the EU need to incorporate the EMA's positive opinion concerning its use in individuals aged 4 to 60.

Ensure compliance with the updated reference list and adjust internal regulatory monitoring processes to align with the inclusion of new biologicals.

Regulatory requirements for daratumumab will need to be reviewed in light of the orphan designation status granted by the EMA.

Pharmacovigilance teams must adopt a structured classification approach to risk analysis, impacting how cases are assessed and notified.

Small business dispensers are encouraged to complete a mandatory assessment survey by September 22, 2026, and do not need to submit information to the FDA while utilizing these exemptions.

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