Europe - EMA releases its revised Q&A document on OOS ATMPs

The EMA has released a revised version of its Questions and answers on the use of out-of-specification batches of authorised cell/tissue-based advanced therapy medicinal products.

Importantly, the document mainly introduces a periodic EMA review.

• MAHs must submit a Quality Defect Report every 6 months to EMA, covering:

  • All OOS batches administered under Section 11.5 of the ATMP GMP guideline
  • Comparison with compliant batches released in the same period
  • Assessment of process consistency and specification adequacy
  • Identification of trends and potential process improvements
• EMA shares this review with the CAT Rapporteur, and may request further data or initiate regulatory action if trends are detected.

As a reminder, this document addresses the exceptional administration of out‑of‑specification batches and focuses on patient safety in exceptional clinical need, roles and responsibilities of MAH, manufacturer, importer, QP as well as EU and national regulatory oversight mechanisms.

The document is of high important to Kite, as this revision clarifies responsibilities, streamlines notification pathways, and introduces a structured periodic oversight mechanism at EU level for OOS ATMPs

Reference document: EMA Questions and answers on the use of out-of-specification batches of authorised cell/tissue-based advanced therapy medicinal products