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Sign in to saveA new draft guideline on user safety for pharmaceutical veterinary medicinal products is now open for consultation, replacing the previous guideline. This impacts applications for marketing authorisations (MA) and variations concerning user safety risk assessments.
This guideline is significant as it provides clarity on the processes and requirements for conducting user safety risk assessments, ensuring that MA holders and sponsors adhere to the latest regulatory expectations.
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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.
