Primary source: EMA - Regulatory and procedural guidelines RSS
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Sign in to saveMember states must now be contacted before the launch of QR codes when content provided includes information beyond the statutory product information, thereby establishing a structured communication requirement.
This change increases the need for compliance and coordination among stakeholders, ensuring that any additional information provided via QR codes is reviewed and approved at the national level.
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PV teams should update workflows and SOPs to include the new section 19A approval processes and ensure compliance with the TGA's guidelines for managing medicine shortages.
PV teams should update their workflows regarding inspection readiness, review standard operating procedures (SOPs) to align with the new GCP inspection coordination processes, and ensure that all relevant personnel are trained on the updated guidance.
PV teams should review and update their Standard Operating Procedures (SOPs) related to real-world data collection methodologies and ensure alignment with the new guidance emerging from the workshop. Training may also be required to enhance understanding of RWD's impact on regulatory submissions.
PV teams should update their regulatory intelligence monitoring workflows to include the timelines and requirements established by the EMA for thalassaemia treatments. It's essential to ensure adherence to the new guidelines in clinical trial designs.
