Developing a regulatory framework for precision medicine products: A Singaporean point of view

Global Congress on Tissue Engineering, Regenerative & Precision Medicine

December 1-2, 2016 | San Antonio, USA

Andrew Green

National University Hospital, Singapore

Scientific Tracks Abstracts: J Tissue Sci Eng

Abstract :

Precision medicine is a robust field in health care that is distinguished by its reliance on genomic technology to deliver customizable preventive and curative treatments to a group of individuals. Like many other countries, Singapore is exploring ways to effectively facilitate the entry of precision medical products into its market. At present, these products are still subject to the same licensing procedures and standards as their "non-precision" counterparts. However, there are compelling reasons to believe that current legislations may not be ideal to effectively regulate this group of products. Firstly, as precision medical products are rarely used in solitaire, licensure of one product may inadvertently rely on the licensure of others it is bundled with. Secondly, this licensure interdependence may delay bringing innovative products into the market. Finally, in the backdrop of a lengthened premarket phase, industry may opt to "personalize" products at the clinical setting instead to escape from licensure requirements. This presentation serves as a systematic appraisal of Singapore's regulatory preparedness in ushering the era of precision medicine, specifically in terms of its ability to: keep up with technological advancements, adequately cover a diverse range of products, nurture innovation, and safeguard public health.

Biography :

Andrew Green obtained his Medical Degree from Duke-NUS Graduate Medical School Singapore in 2012. He has also held a Masters of Science from the Max Planck Institute Tuebingen, Germany and a Masters of Public Health from the National University of Singapore. He is currently a senior resident in Preventive Medicine and concurrently holds the position of assistant director-equivalent at the Health Sciences Authority Singapore. His current portfolio includes the development of a national regulatory framework for advanced therapeutic products and precision medicine. Furthermore, he is also actively involved in Pharmacovigilance, health product compliance, and regulatory impact analysis.

Email: andrew_green@hsa.gov.sg