Primary source: Safety monitoring and information
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Sign in to saveA requirement has been established for sponsors to notify the TGA of medicine shortages or discontinuations affecting reportable medicines, including specific reporting timelines depending on the shortage's impact rating.
This change enhances compliance and monitoring processes across the pharmaceutical industry, ensuring timely reporting of medicine availability issues, which is critical for patient care.
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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.
