Department of Drug Regulatory Affairs, BVDU Poona College of Pharmacy, Pune, Maharashtra, India.
Department of Pharmaceutics, BVDU Poona College of Pharmacy, Erandwane, Pune, 411038, Maharashtra, India.
Ther Innov Regul Sci. 2020 May;54(3):552-558. doi: 10.1007/s43441-019-00087-1. Epub 2020 Jan 6.
The purpose of the present review is to summarize the current pediatric regulatory requirements and also the regulatory efforts that need to be taken for the potential benefits of safety and efficacy to the pediatric patients. The importance of pediatric regulations came into existence as adult physiological conditions differ from that of children; therefore, the same dosage regimen cannot be recommended for both. Children deviate from adults with respect to pharmacokinetic and pharmacodynamic characteristics, and hence the effect of the drug has to be reconfirmed for pediatrics. Drugs used in pediatric clinics are often considered as "therapeutic orphans" throughout the world as they are difficult to develop and are not provided with sufficient information. The number of clinical trials performed in children is not sufficient. At present, laws and regulations aimed at drug development in the pediatric field have not been focused significantly. There are different regulatory bodies that administrate the pediatric regulations for a particular region.
本次综述的目的是总结当前儿科监管要求，以及为了确保儿科患者的安全性和疗效而需要进行的监管工作。儿科监管的重要性在于，成人的生理状况与儿童不同，因此不能为两者推荐相同的剂量方案。儿童在药代动力学和药效学特征上与成人存在差异，因此必须重新确认药物对儿科的疗效。儿科诊所使用的药物通常被认为是全世界的“治疗孤儿”，因为它们难以开发，并且没有提供足够的信息。在儿童中进行的临床试验数量不足。目前，针对儿科领域药物开发的法律法规并没有得到显著关注。不同的监管机构负责管理特定地区的儿科监管法规。
