@isabelarizzardi
Regulatory science is essential in protecting and promoting global public health by giving the scientific basis for ensuring that drugs, medical products, and food are effective, safe, and properly labeled. The pioneering research has historically public health tragedies. In the 20th Century, the first regulatory science research was developed, supporting the regulatory policy decisions. [1]
Regulatory science has been recognized as an important field in the area of pharmaceutical regulation. Unbiased, scientific, and objective assessments based on available data and information can identify the truth and determine the value of science to society in advancing public health. From this perspective, regulatory science can be viewed as important in finding practical and updated solutions for issues of scientific uncertainty and limitations. [2]
The Regulatory Science approach five steps, the first is issues in pharmaceutical regulation, which are new scientific data or information; then analysis of the current situation, which investigate, research and assessment. Based on this analysis, a proposal for improvement is realized in society. Then regulatory actions such as publishing guidelines, and changes to drug labeling may impact and confirm the situation improved. [2]
For the development of new tools and the training of international scientists, new collaborations and partnerships are required. The research training is an effective way to advance regulatory science provided, ensuring the availability of safe products and the capability to monitor the outcomes of consumer use of products in the global market. [1]
The engagement of a wide range of disciplines in medical, pharmaceutical, statistical, technological sciences, and jurisprudence will be important in increasing research activities in Regulatory Science.
References :
[1] Meghal Patel, Margaret Ann Miller. Impact of regulatory science on global public health. The Kaohsiung Journal of Medical Sciences. Volume 28, Issue 7, Supplement. 2012. Pages S5-S9. ISSN 1607-551X. Available in <https://doi.org/10.1016/j.kjms.2012.05.003.>
[2] Yoshiaki Uyama. The importance of a regulatory Science approach for better pharmaceutical regulation. Translational and regulatory sciences. Volume 1, Issue 1. 2019. Pages 8-11. ISSN 2434-4974. Available in <https://doi.org/10.33611/trs.1_8>
