Regulatory Guidance for Pharmaceutical Nanotechnology

Nanotechnology represents a platform for developing revolutionary changes and improvements to many different aspects of pharmaceutical manufacturing. Also, the rate of nanotechnology discovery is proceeding more rapidly than practical applications can be found. Nanotechnology offers potential in pharmaceuticals for improving drug delivery systems, medical imaging, diagnosis, cancer therapy, and regenerative medicine. Although there is no international regulation or legislation specifically for nanomedicine, it is agreed worldwide that considerably more attention should be paid to the quality, safety, and efficacy of nanotechnology-based drugs. The US FDA and the European Medicines Agency have provided several regulatory guidelines for the development of nanomedicines.

  • Enable major investments and advances in basic sciences to translate faster into products to benefit consumer
  • Protect consumers by applying best possible science to support regulatory activities and decision-making
  • Keep pace with and fully utilize advances in innovation
  • Facilitating development of innovative products that benefit consumers and patients
  • Regulatory aspects towards approval of nanomedicine

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