Primary source: Download the Draft Guidance Document
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Sign in to saveNew standards and timelines for electronic submissions of PMAs have been proposed, including a 60-day comment period and anticipated technical screening within 15 calendar days. The guidance will also establish criteria for exemptions from electronic submission requirements.
These updates are crucial for all MAHs and sponsors involved in PMAs, as they represent a shift towards electronic submission formats intended to streamline the regulatory process and enhance compliance.
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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.
