Pharma-Guidelines-Nanodrug003
Technical Guiding Principles for Non-clinical Safety Research of Nanomedicines (Trial Implementation) (English Version)

Standard No.

Pharma-Guidelines-Nanodrug003

Language

Chinese, Available in English version

Release Date

2021

Published By

National Health Commission of the People's Republic of China

Scope

Nanomedicine as mentioned in this guideline refers to nanoscale particles made from raw materials using nanopreparation technology, or nanoscale particles formed by combining raw materials with appropriate carrier materials, and their final products. Pharmaceutical preparations. Nanomedicines are usually divided into three categories: drug nanoparticles, carrier nanomedicines and other nanomedicines. For the scope, characteris ics and classification information of nanomedicines, please refer to the "Technical Guidelines for Nanomedicine Quality Control Research (Trial)". Nanomedicines have relatively special biological properties due to their special physical and chemical properties such as nanoscale effects and nanostructure effects. Nanomedicines may be highly selectively dis ributed in specific organs, tis ues, cells, and intracellular structures in the body through passive targeting, active targeting, physical targeting, chemical targeting, etc., changing the pharmacokinetic characteris ics of the prototype drug. Such as tis ue dis ribution in the body, which in turn affects its safety and effectiveness. Similarly, due to the particularity of nanomedicines, the non-clinical safety evaluation strategies suitable for ordinary drugs may not be completely suitable for nanomedicines. In addition to conventional toxicological evaluation, there are many special concerns. By obtaining relatively comprehensive non-clinical safety research data, the potential ris s of nanomedicines can be fully considered and fully assessed to provide information for their clinical trial design and rational clinical use of drugs. This guiding principle applies to drug nanoparticles and carrier nanomedicines, but does not apply to other types of nanomedicines. The drafting of this guideline is based on the current scientific understanding of nanomedicines. With the progress and experience accumulation of nanomedicine scientific research, the relevant content will be continuously improved and updated in a timely manner.