Dri Diego Alejandro, Marianecci Carlotta, Carafa Maria, Gaucci Elisa, Gramaglia Donatella
Clinical Trials Office, Italian Medicines Agency (AIFA), Via del Tritone 181, 00187 Rome, Italy.
Department of Chemistry and Technology of Drugs (DCTF), University of Rome "La Sapienza", Piazzale Aldo Moro 5, 00185 Rome, Italy.
Pharmaceutics. 2021 Mar 13;13(3):381. doi: 10.3390/pharmaceutics13030381.
Advances, perspectives and innovation in drug delivery have increased in recent years; however, there is limited information available regarding the actual presence of surfactants, nanomedicines and nanocarriers in investigational medicinal products submitted as part of a request for authorization of clinical trials, particularly for those authorized in the European Economic Area. We retrieve, analyze and report data available at the Clinical Trial Office of the Italian Medicines Agency (AIFA), increasing the transparency and availability of relevant information. An analysis of quality documentation submitted along with clinical trials authorized by the AIFA in 2018 was carried out, focusing on the key terms "surfactant", "nanomedicine" and "nanocarrier". Results suggest potential indications and inputs for further reflection and actions for regulators to actively and safely drive innovation from a regulatory perspective and to transpose upcoming evolution of clinical trials within a strong regulatory framework.
近年来，药物递送领域的进展、前景和创新不断增加；然而，关于作为临床试验授权申请一部分提交的研究用药品中表面活性剂、纳米药物和纳米载体的实际存在情况，可获取的信息有限，特别是在欧洲经济区获批的那些药品。我们检索、分析并报告了意大利药品管理局（AIFA）临床试验办公室提供的数据，提高了相关信息的透明度和可获取性。对2018年AIFA批准的临床试验所提交的质量文件进行了分析，重点关注关键术语“表面活性剂”、“纳米药物”和“纳米载体”。结果为监管机构从监管角度积极且安全地推动创新，并在强大的监管框架内转化临床试验的未来发展提供了潜在的指示和进一步思考及行动的依据。
