1.PQM 2025 First Half Spring Academic Seminar
The PQM 2025 First Half Spring Academic Seminar concluded successfully, thanks to your active participation and strong interest in ELog and HPQR.
This seminar provided a valuable platform to share field-based insights on contamination control strategies, data integrity, regulatory consultations, and GMP violations. We hope the discussions and case studies offered practical guidance and inspiration for your ongoing efforts in quality management.
We look forward to welcoming you again in the second half of the year, with even more engaging content and deeper industry insights.
2. QualityWise.ai – Practical AI Tools for Better Quality Decisions
As AI gains momentum in life sciences, QualityWise.ai offers practical, task-focused tools to support modern quality operations—without overpromising general intelligence.
Powered by machine learning and generative AI, it turns operational data into actionable insights—enabling QA teams to respond faster, smarter, and more strategically.
โ๏ธ Key Features
- Generative AI (Generative AI)
- Natural Language Processing (NLP)
- Machine Learning-Based Functions (e.g., auto-categorization, summarization)
๐น AI-Powered Auto-Categorization
Classifies quality records automatically to save time and improve accuracy.
๐น Generative AI Summarization
Summarizes quality events consistently to support faster decision-making.
๐น Data-Driven Quality Insights
Reveals hidden patterns to enable proactive quality management.
QualityWise.ai helps leading companies accelerate RCA, optimize CAPA, and drive digital QMS transformation.
3. Regulatory Insight: Korea MFDS Post-Marketing Safety Reform
In February 2025, Korea’s MFDS enacted major legal reforms to shift the focus of post-marketing drug safety from PMS (Post-Marketing Surveillance) to RMP (Risk Management Plan).
โถ Key Legal & Regulatory Changes
โ Pharmaceutical Affairs Act Amendment (Feb 20, 2025)
- Unified post-marketing safety systems under Risk Management Plans (RMP)
- Abolished the traditional re-examination system
- Expected expansion of RWD/RWE-based safety evaluations
โ Terminology
- RWD (Real-World Data): Health-related data collected in real-world settings, such as EHRs, claims data, and patient registries
- RWE (Real-World Evidence): Clinical evidence derived from RWD to assess the safety and effectiveness of drugs
โก Enforcement Rule Amendment for Drug Safety (Feb 21, 2025)
- Specified RMP submission targets and required components at the Prime Ministerial Decree level
- Guidelines upgraded to binding legal standards
- Strengthened requirements for clinical data and RMP documentation
โข Enactment of RMP Operation Regulation (Feb 28, 2025)
- Defined legal obligations for RMP execution, data submission/retention, and roles of safety officers
- Regulatory formalization signals a stronger compliance enforcement ahead
๐ Read Full Insight (Korean) Read Full Insight (Korean)
4. FDA News Alert – Crackdown on Overseas Genetic Trials
๐น FDA Suspends New Trials that send American citizens’ living cells to China and other adversarial countries for genetic engineering.
๐น Lack of Participant Consent: Investigations reveal some trials failed to inform patients their cells were sent overseas and genetically altered.
๐น National Security Risk: Potential misuse of U.S. genetic data by foreign governments, including those partially linked to adversarial regimes.
๐น Policy Reversal: FDA halts previous exemptions that allowed the export of biological samples under the 2024 Biden-era data rule.
๐น New Standards: Clinical trials must now ensure full transparency, domestic data handling, and ethical consent to proceed.
๐ Read the FDA News Release (June 18, 2025)
5. FDA Introduces Vouchers to Speed Up Drug Review
๐น New Incentive Program: The FDA announced it will issue special review vouchers to drug developers as part of a broader effort to accelerate approval timelines.
๐น Eligibility: Companies that meet pre-defined innovation or public health impact criteria may apply.
๐น Review Time Reduced: Each voucher can shorten the FDA's review process from the standard 10 months to as little as 6 months.
๐น Transferable Benefit: These vouchers can be sold or transferred to other developers—encouraging participation and investment in high-impact treatments.
๐น Policy Goal: The FDA aims to encourage development of groundbreaking therapies while maintaining rigorous safety standards.
๐ Read the Reuters Article (June 17, 2025)
๐ฉ Inquiries & Demo Requests: