Implementation of the European Shortages Monitoring Platform (ESMP) for National Competent Authorities (NCAs)

PV teams should update relevant SOPs to include workflows for monitoring the monthly PRAC recommendations and ensure compliance with timely amendments to product information based on these safety signals.

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.