By Fineline Cube 
China’s Center for Drug Evaluation (CDE) released a draft guideline titled “Scope, Classification and Definitions of Advanced Therapy Medicinal Products (ATMPs)” for public consultation until July 10, 2025. This marks a significant step toward standardizing the regulatory framework for innovative therapies.
Definition and Scope of ATMPs
The draft defines ATMPs as cell therapeutic drugs and gene therapy drugs developed, manufactured, distributed, used, and regulated as pharmaceutical products under Chinese law. These products are produced via in vitro manipulation and exert intended functions in humans. It also includes other drugs produced through innovative microbial, cellular, genetic, or tissue-engineering technologies.
Global Consistency
Aligning with international standards, the CDE adopts the term “ATMPs,” consistent with the European Medicines Agency (EMA) and the World Health Organization (WHO), differing from the FDA’s “Cellular and Gene Therapy Products (CGTs)” and Japan’s “Regenerative Medicinal Products (RMPs).” Preventive vaccines and conventional microbiome products, such as probiotics, are explicitly excluded from this definition.
Inclusion Criteria
Xenogeneic-cell, tissue, or organ-derived products, such as gene-edited porcine organs for transplantation, qualify as ATMPs if they rely on biological activity, immune modulation, or tissue regeneration. Additionally, synthetic biology-based products may be included if they meet the technical criteria for ATMPs.-Fineline Info & Tech