Quick overview of drug administration policies (issue 43) speed up the improvement of drug technology guiding principle system

The 2021 annual drug evaluation report shows that the drug administration department is committed to building a scientific, authoritative and open evaluation standard system. 87 guiding principles were issued in 2021, and a total of 361 guiding principles have been issued, covering traditional Chinese medicine, chemical drugs, biological products and other fields, including hot and difficult issues such as novel coronavirus therapeutic drugs, ancient classic prescriptions, cells and gene therapy, It provides scientific and powerful technical support for the innovative development of the pharmaceutical industry and drug evaluation.

In promoting the research and development of covid-19 treatment drugs, the guiding principles such as the guiding principles for non clinical research technology of covid-19 neutralizing antibody drugs (Trial), the guiding principles for non clinical pharmacodynamic research and evaluation technology of anti novel coronavirus pneumonia inflammatory drugs (Trial) were issued.

In terms of promoting the inheritance, innovation and development of traditional Chinese medicine, the guiding principles for the writing of instructions for traditional Chinese medicine compound preparations of ancient classic prescriptions (Trial), and the guiding principles for the writing of theoretical application materials for traditional Chinese medicine compound preparations of new traditional Chinese medicine (Trial) were issued.

In terms of promoting the research and development innovation of children's drugs, the guiding principles such as the guiding principles for clinical trials of improved new drugs for children's Chemicals (Trial), the guiding principles for the writing of information related to children's drugs in the instructions of chemical drugs and therapeutic biological products (Trial) were issued.

The formulation and release of relevant guiding principles further improved the drug evaluation system and provided strong technical support for scientific and fair decision-making.