Regulatory challenges for nano therapeutics

2^nd International Conference and Exhibition on Pharmaceutical Regulatory Affairs

November 23-24, 2012 Hyderabad International Convention Centre, India

Lakshmi Durga Vemuri, Sravani Angaru, N.Vishal Gupta and H.V.Raghunandan

Posters: Pharmaceut Reg Affairs

Abstract :

Nanomedicines are just beginning to enter drug regulatory processes, but within a few decades could comprise a dominant group within the class of innovative pharmaceuticals, the current thinking of government safety and cost-effectiveness regulators appearing to be that these products give rise to few if any nano-specific issues. There are also significant public good aspects to the regulation of nanotechnology, particularly with regard to ensuring that industry involvement in standard-setting does not become a means of reducing competition and that nanotechnology policy and regulation encourages new models of safe drug discovery and development more systematically targeted at the global burden of disease. There is no international regulation of nanoproducts or the underlying nanotechnology. Nor are there any internationally agreed definitions or terminology for nanotechnology, no internationally agreed protocols for toxicity testing of nanoparticles, and no standardized protocols for evaluating the environmental impacts of nanoparticles. In the US, the EPA's nanomaterials stewardship program (NMSP), launched in 2008 and due to be concluded in 2010, was split into two: the basic program, whereby companies were simply required to submit information about the materials they produce; and the in-depth program, which offered companies the opportunity to work with the EPA to identify what additional information might be useful in regulatory decision-making, and to devise methods to generate this information. The European Union has formed a group to study the implications of nanotechnology called the Scientific Committee on Emerging and Newly Identified Health Risks which has published a list of risks associated with nanoparticles.

Biography :

Lakshmi Durga Vemuri is a student of JSS College of Pharmacy, JSS University, Mysore, Karnataka, India. She has completed her B. Pharm from Chalapathi institute of pharmaceutical sciences,Guntur, Andhrapradesh during the year 2012. Presently she is pursuing M Pharm in Pharmaceutical Quality Assurance in JSS College of Pharmacy, Mysore. She has attended various National and International Conferences. Her current areas of interest are Quality Assurance, Regulatory Affairs, Quality Management Systems, GMP Auditing and analytical method development.