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Sign in to saveThe EMA clarified that storage sites for master and working cell banks must be documented in the Common Technical Document (CTD), while active substances, finished products, and intermediates do not require site registration. Additionally, reprocessing must be explicitly mentioned if applicable, and details regarding the composition of media components and microbial control measures are now mandatory for submissions.
These changes establish clearer expectations for the quality and safety assessment of biological medicinal products, enabling more consistent submissions and aiding in the regulatory review process. Improved guidance on reprocessing and microbial control can also mitigate risks associated with biological product manufacturing.
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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.
