Volume 30 follows up on the PQM spring seminar and looks at quality-data tools and regulatory developments in Korea and the United States.
PQM spring seminar follow-up
The PQM 2025 First Half Spring Academic Seminar covered contamination control strategies, data integrity, GMP consultation, and inspection findings. Connexo’s discussions with attendees included interest in ELog and HPQR.
The case studies gave participants examples of how quality and regulatory issues are handled in daily operations. Connexo plans to continue those conversations at the second-half event.
QualityWise.ai for quality-data review
QualityWise.ai uses machine learning, natural language processing, and generative AI to categorize quality records, summarize events, and identify patterns in operational data. These functions support root cause analysis and CAPA review by helping teams organise and examine the information already in their systems.
Post-marketing safety reform in Korea
Korea’s 2025 post-marketing safety reforms bring the former re-examination system into a risk management plan (RMP) framework. The change puts the planning, collection, and review of safety information within a more unified approach.
The reform also draws attention to the use of real-world data and evidence. Real-world data includes information from health records, claims, and registries; real-world evidence is the clinical evidence produced by analyzing that information.
Read the Korean-language overview of the reform.
FDA review of overseas cell-processing trials
On June 18, 2025, the FDA announced a review of trials involving the transfer of U.S. participants’ living cells to China and other countries it identified as hostile for genetic engineering. The agency cited concerns about informed consent and the handling of sensitive biological material, and said new trials that did not meet its stated standards would not proceed.
FDA announces a national priority voucher program
On June 17, 2025, the FDA announced the Commissioner’s National Priority Voucher program for selected drug developers aligned with U.S. national health priorities. The announcement set a target of one to two months for review following a final application submission, compared with approximately 10 to 12 months under the standard process.
The proposed process includes advance submission of manufacturing information and draft labeling, with close communication between the sponsor and the agency. The FDA said it could extend the review where information was incomplete or the application was particularly complex.
Read the FDA’s program announcement and the Reuters report.
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