Primary source: Safety monitoring and information
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Sign in to saveThe TGA has updated its guidance related to the monitoring and management of medicine shortages, including the addition of 25 non-prescription medicines to the list of reportable shortages. There will be an emphasis on earlier notification of discontinuations and a requirement for sponsors of these medicines to report supply issues.
These changes aim to improve the response to medicine shortages, enhancing the availability of vital information for health professionals and patients. Improved communication and mandatory reporting are expected to mitigate the impacts of supply disruptions on healthcare delivery.
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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.
