PHDS HEALTHCARE RESEARCH Co., Ltd.
Clinical Research of Traditional Chinese Medicine
Release time:
2005-09-03
A traditional Chinese medicine compound preparation, 'Angong Zhi Xue Capsule', jointly researched by renowned Chinese medicine experts and combined with modern medical technology, is being conducted by PHDS for Phase II and III clinical trials. Clinical research has been fully launched at six traditional Chinese medicine gynecology clinical bases in the country. The design of its clinical trial protocol is rigorous and scientific, and the operational process fully complies with GCP, making the trial procedures leading in the existing traditional Chinese medicine preparations in the country. It is expected to achieve complete success.
The traditional Chinese medicine compound preparation "An Gong Zhi Xue Jiao Nang" was jointly researched by renowned Chinese medicine experts and combines modern medical technology. The clinical research for phases II and III is conducted by Bo Shi Zhi Xing (PHDS) and has fully launched clinical studies at six traditional Chinese medicine gynecology clinical bases in the country. Its clinical trial design is rigorous and scientific, and the operational process fully complies with GCP, making the trial protocols leading in the existing traditional Chinese medicine preparations in the country. It will achieve complete success.
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Relevant regulations and policies
Key points and judgment principles for the quality management of non-clinical research of drugs
In order to standardize the on-site inspection work of Good Laboratory Practice (GLP) for non-clinical drug research and improve inspection quality, the "Key Points and Determination Principles for the Inspection of Good Laboratory Practice in Non-Clinical Drug Research" has been formulated in accordance with relevant requirements such as the "Drug Administration Law of the People's Republic of China," "Good Laboratory Practice for Non-Clinical Drug Research," and "Management Measures for the Certification of Good Laboratory Practice for Non-Clinical Drug Research."
2024-11-22
Technical requirements for the latest declaration data electronic disc
In order to further improve the quality and efficiency of the preparation of electronic application materials for drug registration, and to standardize the management of electronic application materials, our center has updated the "Technical Requirements for Electronic Discs of Application Materials" and "Structure of Electronic Documents for Drug Registration Applications" published on December 2, 2022, based on feedback.
2024-11-22
In December 2023, PHDS HEALTHCARE RESEARCH Co., Ltd. was elected as the vice president unit of the China Food and Drug Enterprise Quality Safety Promotion Association, as well as the vice chairman of its subordinate digital professional committee (Certificate No.: Zhong Shi Yao An Cu Hui Zheng Zi 798). The election and award ceremony took place at the Three Gorges Hospital of Chongqing Medical University.
2024-11-22
On March 26-27, 2024, the China Wuxi Global Oral Forum and the China Food and Drug Promotion Association High-Quality Development Conference, guided by the Wuxi Municipal People's Government and the Wuxi Council for the Promotion of International Trade, and organized by the China Food and Drug Promotion Association and the Oral Health Committee of the China Food and Drug Promotion Association, will be grandly held at the Wuxi International Conference Center.
2024-11-22
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