Role of regulatory agencies in approval of nanotechnology products

2^nd International Conference and Exhibition on Pharmaceutical Regulatory Affairs

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

Shriya Gupta, Manila Bishnoi, Arvind Sharma and Sandeep Arora

Posters: Pharmaceut Reg Affairs

Abstract :

Regulatory bodies across world have long encountered the combination of promise, risk, and uncertainty that accompanies emerging technologies. Nanotechnology is not unique in this regard. Materials can exhibit new or altered physicochemical properties at nanoscale dimensions, which can enable the development of novel products. The very changes in biological, chemical and other properties that can make nanotechnology applications so exciting, however, also may merit examination to determine any effects on product safety, effectiveness, or other attributes. The application of nanotechnology may result in product attributes that differ from those of conventionally-manufactured products, and thus evaluations of safety or effectiveness of FDA-regulated products that include nanomaterials or otherwise involve the application of nanotechnology should consider the unique properties and behaviors that nanomaterials may exhibit. Consistent with Executive Order 13563 on improving regulation, as well as with the White House policy statements on regulating emerging technologies and applications of nanotechnology, FDA supports innovation and the safe use of nanotechnology in FDA-regulated products under appropriate and balanced regulatory oversight. By enhancing its scientific expertise and tools necessary to assess the safety and, as applicable, effectiveness of products, FDA is maintaining its product-focused, science-based regulatory policy. Where premarket review authority exists, attention to nanomaterials is being incorporated into standing procedures. Where statutory authority does not provide for premarket review, consultation is encouraged to reduce the risk of unintended harm to human or animal health. Industry remains responsible for ensuring that its products meet all applicable legal requirements, including safety standards. Regulatory bodies collaborate, as appropriate, with domestic and international counterparts on regulatory policy issues.

Biography :

Ms. Snehal s. Naingade , doing M.Pharm in Pharmacology at Tatyasaheb Kore College of Pharmacy Warananagar. Presented posters in various conferences.