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EMA Concept Paper: Advancements in Good Manufacturing Practice for Advanced Therapy Medicinal Products

The pharmaceutical industry continually evolves to adapt to new scientific discoveries and technological advancements. Good Manufacturing Practice (GMP) is a system that ensures products are consistently produced and controlled according to quality standards.


Advanced Therapy Medicinal Products (ATMPs) represent a cutting-edge class of medicines, including gene therapies, somatic-cell therapies, and tissue-engineered products. Ensuring their consistent quality and safety during manufacturing is crucial. The European Medicines Agency (EMA) is currently revising the "Part IV Guidelines on Good Manufacturing Practice (GMP) specific to ATMPs" to align with recent regulatory and technological advancements.


ATMPs are medicines for human use that are based on genes, tissues, or cells. They offer groundbreaking new opportunities for the treatment of disease and injury. ATMPs are often classified into three main types: gene therapy medicinal products, somatic-cell therapy medicinal products, and tissue-engineered products.


Why Revise the Part IV GMP Guidelines Now?

The revision is driven by several factors:

  • Alignment with Revised Annex 1 (Sterile Products): The updated Annex 1, effective since August 2023, introduced clearer and more stringent requirements for sterile manufacturing, including contamination control strategies.

  • Incorporation of ICH Concepts: The current ATMP guideline does not fully reflect key International Council for Harmonisation (ICH) principles such as:

    • ICH Q9: Quality Risk Management (QRM) - a systematic approach to identifying and controlling risks.

    • ICH Q10: Pharmaceutical Quality System (PQS) - a modern framework for maintaining product quality and continuous improvement.

  • Technological Advances: New manufacturing technologies such as automated systems, closed single-use systems, and rapid microbiological testing methods have emerged but are not yet addressed.

  • Legal Updates: Changes in regulations concerning substances of human origin require updated definitions and references.


Key Changes Proposed in the Revision

  1. Alignment with Annex 1: The updated guidelines reflect changes in the manufacturing of sterile products, fostering a transition to new manufacturing techniques while maintaining stringent safety standards.

  2. Integration of ICH Concepts: The introduction of Quality Risk Management (QRM) and the Pharmaceutical Quality System (PQS) concepts from ICH Q9 and Q10, respectively. These frameworks allow for better control of product quality and continuous improvement across the lifecycle.

  3. Contamination Control Strategy (CCS): Emphasizing the importance of a systematic approach to prevent contamination during manufacturing, which is critical in the production of ATMPs.

  4. Embrace of New Technologies: Recognition and incorporation of new automated advanced technologies, closed single-use systems, and rapid microbiological testing methods to enhance efficiency and safety.

  5. Legal and Technological Updates: Updating legal references and embracing new technologies in response to the latest regulation on the quality and safety of starting materials of human origin.


Impact and Implementation Timeline

  • The revision is expected to improve clarity and consistency in ATMP manufacturing expectations, facilitating better compliance and product quality.

  • No significant adverse impact on industry resources or costs is anticipated, though gradual facility and process modifications may be necessary.

  • The draft guideline is planned for release in September 2026, followed by a consultation period and final adoption by March 2027.


By integrating updated sterile manufacturing standards, risk management frameworks, and new technologies, the revised guideline will support the safe and consistent production of these complex therapies, ultimately benefiting patients across Europe.

For more detailed information, please refer to the EMA concept paper on the revision of Part IV Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products: EMA Concept Paper on ATMP GMP Revision (2025)

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