A comprehensive study on regulation on clinical trials of pediatrics in US, EU and India
Singh Ajay, Budhwar Vikaas and Choudhary Manjusha
Children have different pharmacokinetic and pharmacodynamics responses as compared to adults. They can also be categorized in different age groups which show different Pharmacokinetics and Pharmacodynamics particularities. Therefore, it becomes necessary to see the effects of optimal dosages and formulations in various age groups of children. The child protection in research was recommended at the Belmont report (1979) first time. The necessity for written informed consent of the subject from a legally authorized representative of a child was described in the Declaration of Helsinki (1964). The United State of America was the first country which made the act for pediatric population clinical trials as the FDA Modernization Act (1997). After that the Best Pharmaceuticals for Children Act (BPCA, 2002) and the Pediatric Research Equity Act (PREA, 2003) were included in the U.S. regulatory framework. These acts cover the incentives for drug developers to conduct (after FDA Written Request) pediatric research and guidelines for conducting clinical trials in children. Similarly to enhance the protection of children in research ‘Pediatric Regulation (EC) No 1901/2006’ was established in Europe in January 2007. It came after the ICH Guidance 11 for conducting research on children. According to this regulation before conducting clinical trials in pediatric population pharmaceutical companies must have a Pediatric Investigational Plan (PIP) and which must be approved by the suitable competent authority. If it is approved six-month patent protection is given to pharmaceutical companies. In India there is no specific act for conducting clinical trials in the pediatric population. Only a section of schedule Y gives information about the requirements of the structure and content of study protocols, informed consent forms and documentation and the composition and functions of ethics committees and includes child patients as deserving special consideration as a vulnerable group. The present article compares the legal provisions and guidelines documented in the US, Europe and India concerned with the clinical trials regulations, incentives and compensation, informed consent etc. of pediatrics.
How to cite this article:
Singh Ajay, Budhwar Vikaas, Choudhary Manjusha. A comprehensive study on regulation on clinical trials of pediatrics in US, EU and India. Pharma Innovation 2016;5(10):16-22.