快速检索
年期检索
摘要： Objective To study the feasibility of developing botanical drugs to treat intractable diseases and play an important role in dealing with major public health crises. Methods From January 1990 to May 2021, a bibliographic search was carried out on the use of botanical drugs, rare disease drugs, related registration management policies and regulations in PubMed and CNKI. The following keywords were searched in the database: Rare disease policies and regulations, orphan drugs, botanical drugs for intractable diseases, botanical drugs for the treatment of new coronary pneumonia, traditional Chinese medicine, and emergency guidelines for major public health crisis. Other data were obtained from “Chinese Pharmacopoeia” and relevant Chinese government websites for sorting and analysis. Results and Conclusion Based on 39 Chinese corresponding policies and regulations, challenges and opportunities of developing and researching drugs for treating rare diseases were found out after the analysis and comparison. Based on the study of national policies on drugs for rare diseases, the priority review and approval procedures in the drug registration, as well as China’s emergency guidelines and policies for major public health events, some problems in the use of drugs for rare diseases are found out. Therefore, it is recommended to actively adopt the property rights protection system, explore the folk prescriptions of traditional Chinese medicine and the potential of hospital preparations, and the registration review strategy of giving priority to the use of botanical drugs for rare diseases. Thus, the international status of botanical drugs for rare disease and the influence of responding to major public health events can be enhanced.
