Objective: To analyze the registration history of traditional Chinese medicine (TCM) generic drugs and the registration application in the past 20 years, explore the development status of medicine with the same name and prescription, and to provide reference for their development. Methods: A systematic analysis was conducted on the changes in the registration policies of TCM generic drugs in China, as well as the general situations such as the registration applications and the approvals for production of TCM generic drugs or drugs with the same name and prescription from 2003 to 2024. The evolution of the registration policy of TCM generic drugs, the characteristics of registration declaration in each stage, and the risks and opportunities of research and development of the medicine with the same name and prescription were discussed. Results: From 2003 to 2024, the registration applications and the approvals for production of TCM generic drugs or medicine with the same name and prescription had obvious policy-driven characteristics, showing a clear three-stage evolutionary process. From 2003 to 2006, there was a rapid increase in the number of registration applications and approved production for “generic standards” with low entry barriers. From 2007 to 2021, there was a high entry barrier for “generic varieties”, and the number of registration applications and approvals plummeted and continued to be low. With the announced of the “medicine with the same name and prescription” in 2020 and the advancement of relevant regulations, both registration applications and approvals have gradually recovered. However, it has not been active since 2022. As of 2024, there have been 6 registration applications for the same name and prescription, with 1 of them approved for market launch. Conclusion: The concept of drugs with the same name and prescription is different from that of generic drugs. Although it has the meaning of the generic drug in chemical medicine, it represents a qualitative improvement in the concept of TCM generic drugs. Currently, the registration applications of drugs with the same name and prescription are mainly for individual varieties. However, in the long term, there may be some regular development model. From the perspectives of variety selection, clinical trials and research risks, the development of drugs with the same name and prescription presents both opportunities and risks.