Full
Outline
Advanced therapy medicinal products (ATMPs), as a cutting-edge frontier in the current biomedical sector, hold enormous potential to address unmet clinical medical needs. Nevertheless, such products are confronted with multiple challenges including high technical complexity, distinctive research and development risks and substantial investment costs. Their accurate classification and scientific regulation are critical to advancing the standardized development of the industry. Over years of practical experience, the European Medicines Agency (EMA) has established a robust legal and regulatory system, accompanied by a series of issued guidelines, thus forming a relatively mature regulatory framework. Furthermore, relying on the Committee for Advanced Therapies (CAT), the EMA has developed a comprehensive mechanism for the classification, designation, and communication of ATMPs, which serves as an important reference for the global regulation of ATMPs. This paper systematically elaborates on the classification criteria and designation procedures of ATMPs formulated by the EMA, and introduces its practical communication practices, including scientific advice and innovation task force briefings. This paper provides insights and references for improving China’s ATMP classification management system, optimizing the evaluation and communication mechanism, and constructing a scientific and efficient regulatory framework.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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