Practical implication
Sponsors and MAHs must review and align safety data collection and reporting protocols with the newly adopted guidelines while preparing for implementation of PRAC recommendations stemming from this meeting.
The EMA's CHMP has outlined significant updates for sponsors and marketing authorization holders (MAHs) regarding the treatment of thalassaemia and sickle cell disease. The new clinical guidelines will be open for public consultation for 4 months, and associated PRAC recommendations will affect pharmacovigilance protocols.
What changed: Adoption of draft clinical guidelines for thalassaemia and sickle cell disease for a 4-month public consultation, and adoption of PRAC recommendations regarding post-authorisation pharmacovigilance outcomes.
Why it matters: These guidelines will establish new safety data collection and reporting protocols important for the ongoing management and oversight of medicines marketed for these conditions, ensuring alignment with updated scientific and regulatory expectations.
Practical implication: Sponsors and MAHs must review and align safety data collection and reporting protocols with the newly adopted guidelines while preparing for implementation of PRAC recommendations stemming from this meeting.
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