About Us
Company Profile
Corporate Culture
Development
Organizational
Responsibility
Partners
Business Scope
CRO Services
Transformation Of Hospital Preparations
Registration Affairs
Medical Services
Cultivation Of Major TCM Varieties
SMO Service
Therapeutic Area
Breathe
Gynecology And Reproductive Medicine
Pediatrics
Tumor
Orthopedics
Cardiovascular And Cerebrovascular
Digestion
Endocrinology And Metabolism
Dermatology
Proctology
Urology
Neurological And Psychiatric Disorders
Qualification And Honor
Qualification And Honor
News
Company News
Industry News
Contact Us
EN
中文 EN
Company News
Industry News
Home - News and Information
Industry News
2026-10-22
CDE Releases 61 General FAQs — Full Compilation of TCM-Related Questions
CDE issued 61 general FAQs covering drug R&D, registration and variations. This compilation extracts 41 TCM-focused questions, mainly involving TCM variety protection application, verification, extension, same-variety protection rules, and technical requirements for Class 3.1 classical prescription preparations. It clarifies clinical trial design, quality control of toxic herbs, reference sample preparation, origin selection, stability study and quality standard development, providing practical regulatory guidance for MAHs and TCM R&D teams.
Learn more
2026-10-13
Nine TCM Products Switched to OTC: Analysis of NMPA CDE Technical Review Logic
Nine TCM products were approved by NMPA to switch from prescription to OTC status. This article analyzes the technical review logic adopted by the Center for Drug Evaluation. Different review priorities are set for topical preparations, extended dosage forms, cough medicines, purgative formulations, cold-natured herbs, compatibility-risk preparations and chronic disease adjuvant products respectively. The core of the evaluation is to set clear self-diagnosis scope, safety exit rules and prominent warnings, ensuring suitability for consumer self-medication. It also summarizes three critical points for enterprises preparing prescription-to-OTC switch applications.
Learn more
2026-10-12
Transition of Procedures for TCM Variety Protection – NMPA Announcement No.97 of 2026
NMPA issued Announcement No.97 of 2026 to set transitional procedural rules for TCM variety protection. This article compares it with the 2009 Guidance, covering applicants, verification, supplementary data, objection procedures and same-name same-formula TCM. Aligned with the MAH system, the new rules feature stricter time limits and stronger protection barriers. It summarizes practical suggestions including pre-submission review, pre-application communication and variety risk screening for MAHs to avoid common pitfalls in application.
Learn more
2026-08-14
External Expert Reappointment List of the Center for Drug Evaluation (2026 First Batch) (Draft for Comments)
In order to ensure the scientific and impartial nature of drug evaluation and fully leverage the role of external experts in the drug review process, and in accordance with the Measures for the Management of External Experts of the Center for Drug Evaluation, the Center for Drug Evaluation has organized and carried out the reappointment of external experts. External experts submitted reappointment applications to the Center based on factors such as personal willingness, age, and conflicts of interest. After review by the Center in accordance with established procedures, the External Expert Reappointment List of the Center for Drug Evaluation (2026 First Batch) (Draft for Comments) has been formulated.
Learn more
2026-08-10
Four Departments Jointly Issue: The New Edition of the Good Clinical Practice for Drug Trials Is Here!
Today (June 8), in order to optimize the quality management of drug clinical trials, further cultivate a standardized and efficient clinical R&D ecosystem, and support biopharmaceutical R&D innovation, the National Medical Products Administration, together with the National Health Commission, the National Administration of Traditional Chinese Medicine, and the National Disease Control Administration, issued the revised Good Clinical Practice for Drug Trials (Announcement No. 50 of 2026).
Learn more
2026-07-09
Notice on the Issuance of the National Essential Medicines List (2026 Edition)
In order to implement the decisions and arrangements of the Party Central Committee and the State Council, and to consolidate and improve the national essential medicines system, and in accordance with the Basic Healthcare and Health Promotion Law, the Drug Administration Law, and other legal provisions, the National Health Commission has organized the updating and revision of the National Essential Medicines List (2018 Edition), and has formulated the National Essential Medicines List (2026 Edition).
Learn more
1
2
Online Message

With a professional and efficient service system and a comprehensive operational network, Guangzhou Evidence Based Medicine is committed to providing tailored one-stop traditional Chinese medicine research and development full industry chain service solutions for every customer, promoting traditional Chinese medicine to the world and safeguarding the health of more people.

The business area you want to consult