FDA and EMA Requirements Converge for Cell and Gene Therapy CMC, but GMP Gaps Persist

In a recent interview with BioPharm International®, Dr. Yelena Ionova, senior manager, Data Strategy and Analytics, of Redica Systems, discussed how evolving expectations from the US Food and Drug Administration (FDA) and European Medicines Agency (EMA), coupled with rising inspection volume, are reshaping compliance strategies for CGT and advanced therapy medicinal products (ATMPs). Dr. Ionova is presenting at the 2026 AAPS National Biotechnology Conference, which is running May 11–14 in San Diego, Calif. In her conference presentation, “Compliance in Cell and Gene Therapy Manufacturing: Anticipating Global Trends,” Dr. Ionova discussed the updating and consolidation of the guidance for CGT products from the FDA and EMA, with a heavy emphasis on chemistry, manufacturing, and controls (CMC). The FDA has introduced a more explicit risk-based, phase-appropriate framework, while the EMA’s new investigational ATMP guideline pulls multiple documents into a single, CMC-focused reference. At the level of documentation and dossier expectations, she said, the two agencies now look “largely aligned.”

However, what regulators expect on paper and what inspectors see on the manufacturing floor often diverge. “When you read the quality documentation section in that guideline, the content is largely similar to the FDA submission process, which does signal meaningful convergence, but operationally, there are still significant divergences that remain,” Ionova says. Her review of recent FDA inspection reports for CGT facilities shows that the most frequent issues are not exotic or uniquely CGT-specific, but rather core quality system problems. These include weak quality unit oversight, incomplete or delayed deviation handling, gaps in corrective and preventive actions, and superficial QA review.

Manufacturers are also running into trouble with production and sterile controls. Ionova pointed to the way many cell therapy operations still rely on open processing in biological safety cabinets, which can create more opportunities for contamination than traditional closed systems used in other biologics manufacturing. Training and operator competency, especially in these complex and manual environments, remain a recurring concern.

Data integrity has not yet emerged as a dominant deficiency in CGT facilities, in part because many sites are newer and are implementing electronic systems from the start. Ionova framed this as a narrow but important opportunity: organizations that build strong data governance and quality-by-design principles into their platforms now may be better positioned to avoid the disruptive, retrospective fixes seen across traditional pharma.

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About the speaker

Yelena Ionova, Pharm.D., Sr Manager, Data Strategy and Analytics, Redica Systems

Yelena Ionova, Pharm.D., is a regulatory data strategy leader with expertise in quality compliance analytics, regulatory intelligence, and post-market surveillance. She serves as Senior Manager of Data Strategy & Analytics at Redica Systems, leading initiatives that support quality risk management for pharmaceutical and medical device companies. Previously, she worked as a regulatory consultant, postdoctoral scholar at UCSF, and fellow at the U.S. Pharmacopeia Quality Institute. Ionova earned her Pharm.D. from UCSF and dual bachelor’s degrees from UC Berkeley. She is also a Certified Quality Science Professional (CQSP).