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2022-09-22
To provide scientific guidance for enterprises in the rational development of combination drugs and further clarify the technical standards for clinical trials, the Center has drafted the “Technical Guidance Principles for Clinical Trials of Combination Drugs (Exposure Draft).” After internal discussion within the Center, the exposure draft has now been finalized.
2022-09-22
To guide sponsors of clinical trials in conducting protocol amendments during clinical trials in a standardized manner, under the guidance of the National Medical Products Administration, the Center for Drug Evaluation has developed the “Technical Guidance Principles for Protocol Amendments During Clinical Trials (Trial)” (see attachment). In accordance with the requirements set forth in the “Notice of the Comprehensive Division of the National Medical Products Administration on Issuing Procedures for the Publication of Pharmaceutical Technical Guidance Principles” (NMPA Comprehensive Drug Administration [2020] No. 9), and following review and approval by the National Medical Products Administration, these principles are hereby promulgated and shall take effect from the date of their publication.
2021-04-15
To further guide and standardize sponsors’ use of real-world data to generate real-world evidence in support of drug development, the Center for Drug Evaluation has organized the drafting of the “Guiding Principles for Real-World Data Used to Generate Real-World Evidence (Trial)” (see attachment).
2021-01-18
To further standardize and guide the quality research of new traditional Chinese medicine (TCM) products and promote high-quality development of the TCM industry, the Center for Drug Evaluation, under the guidance of the National Medical Products Administration, has organized the drafting of the “Technical Guidance Principles for Quality Research of New TCM Products (Trial)” (see attachment).
2021-01-04
To further standardize the management of clinical research, enhance the quality of clinical studies, promote the healthy development of clinical research, and improve the capacity of medical and health institutions in diagnosing, treating, preventing, and controlling diseases, we are now publicly soliciting comments from the public.
2020-09-29
To implement the《Drug Administration Law》and the《Traditional Chinese Medicine Law》and to support the enforcement of the《Measures for Drug Registration Management》(Order No. 27 of the State Administration for Market Regulation), the National Medical Products Administration has organized the development of the《Classification of Traditional Chinese Medicine Registration and Requirements for Submission of Application Materials》, which is hereby released.
The new Drug Registration Management Measures will come into effect on July 1, 2020.
2020-03-30
The “Administrative Measures for Drug Registration” were reviewed and approved at the 1st Bureau Meeting of the State Administration for Market Regulation in 2020 on January 15, 2020. They are now promulgated and shall take effect as of July 1, 2020.
The new version of GCP will take effect starting July 1, 2020.
2020-09-25
Good Clinical Practice for Drug Clinical Trials
Guiding Principles for the Data Monitoring Committee of Clinical Drug Trials (Trial Implementation)
2020-09-25
Guiding Principles for the Data Monitoring Committee of Clinical Drug Trials (Trial Implementation)
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