Circular of Center for Drug Evaluation, NMPA on Publishing the Guideline for Writing of Application Documents for Traditional Chinese Medicine (TCM) Theory of New TCM Compound Preparations (Trial)
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.
Guideline for Clinical Trial Technology of Modified New Drugs of Pediatric Chemical Medicine (Trial)
I. Overview
II. Common modification
(1) Development/expansion of pediatric application
1. Expansion of adult’s application to pediatric application
2. Expansion of new pediatric application
(2) Modified pediatric preparation
1. Change of dosage form
2. Change of strength
III. Clinical trial design considerations
(I) Basic principle
(II) Specific considerations
IV. Concerns
(I) Evaluation on clinical advantage of modified preparation
(II) Characteristics of multi-objective optimization preparation
(III) Development of new compound
(IV) Considerations for special or complex dosage form
V. Encouraging communication
Previous Page
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)