Interpretation on Relevant Quality Management Issue of Medical Device Clinical Trial (II)
For the medical device clinical trial conducted in two clinical trial sites, if the clinical trial design conforms to relevant requirements for multi-center clinical trial of the Standards for Quality Control of Medical Device Clinical Trials, clarify one clinical trial site as the lead site. Follow the same trial protocol to concurrently conduct the clinical trial to ensure consistency of implementation of clinical trial protocol and use of trial medical device. For the statistics analysis principle and method for clinical trial above, refer to the multi-center clinical trial requirements. The lead site will summarize the trials conducted by two clinical trial sites, and form the clinical trial report with the seal of two clinical trial sites.
In order to speed up the establishment of an evidence system for the registration and evaluation of Chinese medicine which combines the traditional Chinese medicine (TCM) theory, human experience and clinical trial, standardize the writing of application documents for TCM theory and package inserts for TCM compound preparations of classic famous formula, under NMPA deployment, the Center for Drug Evaluation has coordinated formulation of the Guideline for Writing of Application Documents for Traditional Chinese Medicine (TCM) Theory of New TCM Compound Preparations (Trial) (Attachment 1), and the Guideline for Writing of Package Inserts for TCM Compound Preparations of Classic Famous Formula (Trial) (Attachment 2). In accordance with the Notice of Comprehensive Division, NMPA on Releasing the Technical Guideline for Pharmaceutical Products (YJZYG [2020] 9), after NMPA review and approval, it's hereby released and implemented since the date of release.
Noahpharm Presence in SAPA2021 China
Noahpharm Presence in SAPA2021 China
On October 14-15, 2021, hosted by Sino-American Pharmaceutical Professionals Association – China (SAPA-China), and guided and organized by the Management Committee of Suzhou High-tech Zone and the Management Committee of Suzhou Hushuguan Economy and Technology Development Zone, the Opportunity and Challenge for Chinese Biological Medicine Development and SAPA2021 China kicked off in Shishan International Convention Center in Suzhou High-tech Zone.
In golden autumn, Beijing Noahpharm Co. Ltd moved to a new address on October 11, 2021.The new office is situated in 3rd Floor, Building 11, Zone 4, Hanwei International Plaza, Fengtai Science and Technology Park, Beijing. The superior geological location and convenient transportation shorten our communication distance with customers, helping us meet customers’ demand in a better and faster way. The new location also facilitates employee mobility.
Provisions for the Supervision and Administration of Drug Production (No. 28 Order of the State Administration of Market Regulation, January 22, 2020)