CDER: Global regulatory collaboration seeks to ensure a stable supply of critical oncology biologic

The FDA and the EMA have successfully completed the first collaborative assessment of a proposed post-approval change for a crucial oncology biologic, with the Japanese PMDA as an observer. This collaborative effort involved the FDA and EMA reviewing and approving a proposal to incorporate new manufacturing and quality control sites. The aim of this collaboration is to ensure a consistent supply of the medicine. This achievement is part of an international pilot program under the International Coalition of Medicines Regulatory Authorities (ICMRA) Pharmaceutical Quality Knowledge Management System (PQKMS) initiative.

The program seeks to bring together regulatory authorities to enhance industry quality management, ensuring a dependable supply of essential medicines for patients. This collaboration follows a broader trend of global regulatory bodies working together to tackle challenges related to drug availability. Manufacturing changes are often made by drug manufacturers to modernize processes and facilities and overcome supply chain obstacles. Depending on the scope of the change, regulators need to evaluate, inspect, and authorize it. As manufacturers distribute the same products across multiple countries, they must navigate diverse regulatory expectations and review timelines. Even a critical manufacturing change can prove intricate and time-consuming to implement.¹

Read more about the successful collaboration between EMA and FDA here.

References

1. Research, C. F. D. E. A. (2023). CDER collaborates with global regulators on pharmaceutical quality assessments and inspections. U.S. Food And Drug Administration. https://www.fda.gov/drugs/news-events-human-drugs/cder-collaborates-global-regulators-pharmaceutical-quality-assessments-and-inspections

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