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In order to enhance the research standards of traditional Chinese medicine injections, strengthen guidance and management throughout the R&D process, and ensure compliance with the requirements of safety, efficacy, quality control, and stability, it is essential to promote further standardization, scientific rigor, and systematic approaches in related research. In addition to following the current edition of the Chinese Pharmacopoeia, particularly its provisions on injectable preparations, as well as the relevant regulations outlined in the "New Drug Approval Measures (1999)" (hereinafter referred to as the "Measures"), specific technical requirements have been established to address the unique characteristics of traditional Chinese medicine injections. These guidelines aim to support a more structured and evidence-based approach to development, ensuring that products meet modern regulatory expectations while preserving the integrity and therapeutic value of traditional formulations. By aligning with both existing standards and the particularities of TCM, this framework supports the long-term quality, consistency, and clinical utility of these medicinal products.