Table 3 Technical guidelines regarding the application of HUE and RWE for registration and regulatory decisions of TCM products
Years | Institution | Guidelines | Main contents |
|---|---|---|---|
2020 | NMPA | Technical Guideline on Using Real-World Evidence to Support Drug Development and Regulatory Evaluation(Trial) | • Clarifying the relevant definitions of RWE • Proposing to utilize RWE to support the clinical development of TCM with human-use experience |
2021 | NMPA | Technical Guideline on Using Real-world Data to Generate Real-world Evidence (Trial) | • Clarifying the sources and current status of RWD • Providing specific requirements and guiding recommendations for RWD in terms of curation, evaluation, governance, standards, safety compliance, and applicability |
2022 | NMPA | Technical Guideline for Clinical Research and Development of New Drugs of Traditional Chinese Medicine Compound Preparations Based on Human Use Experiences (Trial) | • Information on human-use experience • Curation and evaluation of clinical practice data of human-use experience • Strategies for clinical research and development of TCM based on human-use experience • Clinical study design based on human-use experience |
2022 | NMPA | Technical Guideline for Communication under Registration Review Evidence System Based on ‟Three Combinations” (Trial) | • Core issues discussed at the communication meeting for TCM registration under the"three combination"system |
2023 | NMPA | Technical Guideline on the Design and Protocol Development of Real-World Studies for Drugs (Trial) | • Introducing main types of designs for RWS and framework of RWS protocols • Providing considerations for RWS designs, including feasibility of RWS, representativeness of the target population, hybrid study design, and target trial emulation |
2023 | NMPA | Technical guideline for communication of real-world evidence support to drug registration applications (Trial) | • Core issues discussed at the communication meeting • Requirement for communication materials |
2023 | NMPA | Technical Guidelines on Chemistry, Manufacturing, and Controls (CMC) Studies of New Drugs of Traditional Chinese Medicine Compound Preparations Based on Human Use Experiences (Trial) | • Providing recommendation for applicants to conduct CMC research of new drugs of TCM compound preparations based on HUE, mainly focused on formulation, preparation process, dosage form, quality standard and control, stability and bridging study |