Cellular Production Unit, Andalusian Molecular Biology and Regenerative Medicine Centre (CABIMER), Americo Vespucio Avenue s/n, 41092, Seville, Spain,
Clin Exp Med. 2014 Feb;14(1):25-33. doi: 10.1007/s10238-012-0213-6. Epub 2012 Sep 27.
The development of new drugs using stem cells has become a clinic alternative for the treatment of different diseases such as Alzheimer's, diabetes and myocardial infarction. Similar to conventional medicines, stem cells as new medicinal products for cell therapy are subjected to current legislation concerning their manufacture process. Besides, their legality is determined by the Regulatory Agencies belonging to the Member State of the European Union in which they are being registered. With the evolution of therapy that uses cells as medicines, there is a need to develop the appropriate legislative and regulatory framework capable of ensuring their safety and effectiveness. However, few works have been published regarding the regulations that these products must comply through production and commercialization processes. The present work is focused on the description of key events during clinical development and cell production of stem cells as drugs. Such as the regulations, requirements and directives involved in the production of cell therapy medicinal products, from the clinical design stage to its commercialization in Europe.
利用干细胞开发新药已成为治疗阿尔茨海默病、糖尿病和心肌梗死等多种疾病的临床替代方法。与传统药物一样，作为细胞治疗的新药物产品，干细胞的制造过程受现行立法的约束。此外，它们的合法性由其正在注册的欧盟成员国的监管机构决定。随着细胞治疗的发展，需要制定适当的立法和监管框架，以确保其安全性和有效性。然而，关于这些产品在生产和商业化过程中必须遵守的规定，发表的相关文章却很少。本工作重点描述了作为药物的干细胞的临床开发和细胞生产过程中的关键事件。例如，细胞治疗药物生产过程中涉及的法规、要求和指令，从临床设计阶段到在欧洲的商业化。
