Primary source: Safety monitoring and information
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Sign in to saveThe TGA has established new guidance for voluntary data sharing among stakeholders to manage hospital medicine shortages effectively. The implementation of the Dynamic Model of Medicine Availability v2 (DMMA v2) enhances the ability to forecast medicine availability and respond to shortages.
This guidance facilitates proactive management of medicine shortages, ensuring better preparedness and response in hospital settings, which is critical for patient care and 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.
