Ferry Nicolas
Département de thérapie cellulaire, Hôpital Saint Louis, 1 Avenue Claude Vellefaux, 75010 Paris, France. E-mail:
Biomed Mater Eng. 2017;28(s1):S3-S7. doi: 10.3233/BME-171619.
The regulation for the use of stem cells has evolved during the past decade with the aim of ensuring a high standard of quality and safety for human derived products throughout Europe to comply with the provision of the Lisbon treaty. To this end, new regulations have been issued and the regulatory status of stem cells has been revised. Indeed, stem cells used for therapeutic purposes can now be classified as a cell preparation, or as advanced therapy medicinal products depending on the clinical indication and on the procedure of cell preparation. Furthermore, exemptions to the European regulation are applicable for stem cells prepared and used within the hospital. The aim of this review is to give the non-specialized reader a broad overview of this particular regulatory landscape.
在过去十年中，干细胞使用的相关规定不断演变，目的是在整个欧洲确保人类源产品的高质量和安全性标准，以符合《里斯本条约》的规定。为此，已发布了新规定，干细胞的监管地位也已修订。实际上，根据临床适应症和细胞制备程序，用于治疗目的的干细胞现在可归类为细胞制剂或高级治疗药品。此外，欧洲法规的豁免适用于在医院内制备和使用的干细胞。本综述的目的是让非专业读者广泛了解这一特殊的监管情况。
