News and Information
Evidence-Based Empowerment | Lead Site Initiation Meeting for the Bailing Tablets Clinical Trial in the Treatment of Vitiligo Successfully Held
On August 3, the lead site initiation meeting for the clinical trial on the efficacy and safety of Bailing Tablets in the treatment of non-segmental slowly progressive vitiligo was successfully held in the academic hall on the first floor of the Department of Dermatology at the First Affiliated Hospital of Air Force Medical University.
2026-08-03
Insight into Hong Kong & Macao, Building Bridges for Global Expansion" — Evidence-Based Research on the Hong Kong and Macao Registration Pathways for Pharmaceutical Enterprises in the Greater Bay Area
In-Depth Analysis of Compliance Pathways for Greater Bay Area TCM Enterprises "Going Global": A Comprehensive Guide to Hong Kong's HKC Tiered Review Policy, Macao's Fast-Track "Non-Drug" Filing, and Greater Bay Area Two-Way Simplified Registration, with Real-World Case Studies and Key Pitfalls to Avoid
2026-07-25
Good News | Guangzhou EBM Elected as Council Member Unit of the Second Council of the Evidence-Based Medicine Branch, China Ethnic Medicine Association
From June 26 to 29, 2026, the 2026 Annual Academic Conference of the Evidence-Based Medicine Branch of the China Ethnic Medicine Association was grandly held in Hohhot, Inner Mongolia Autonomous Region.
2026-06-30
When a Millennium-Old Classic Formula Meets the "Research-Oriented Pharmacy" – Xiao Chai Hu Granules Real-World Study Project Launched at Beijing Tongrentang Foshan Chain
On the afternoon of June 24, the "Guanghua Xiao Chai Hu Granules – Beijing Tongrentang Foshan Chain Research-Oriented Pharmacy Real-World Study Project" deployment meeting was held at the headquarters of Beijing Tongrentang Foshan Chain Pharmacy. This marks another significant deployment of the project in Guangdong following its launch in Guangzhou, signaling that the nation's first OTC drug research-oriented pharmacy project has officially entered the Foshan market.
2026-06-24
2025 Drug Clinical Trial Volume Reaches New High, Offering New Treatment Options for Patients
The National Medical Products Administration (NMPA) released the 2025 Annual Report on the Progress of New Drug Registration Clinical Trials in China, reporting 5,215 clinical trial registrations for the year, surpassing 5,000 for the first time. Category I innovative drugs accounted for 72.4% of all new drug trials, with Phase I innovative drug trials ranking first globally. The report provides a comprehensive review of clinical trial data across multiple therapeutic areas, including anti-tumor drugs, weight-loss medications, cell and gene therapies, pediatric medicines, and rare disease drugs, while also offering insights into the current state of China’s original innovation capabilities in new drug R&D and the development of international multi-regional clinical trials.
2026-06-24
From Evidence to Intelligent Evidence: Salon on AI New Paradigm for TCM Enterprises Concludes Successfully
On May 28, Guangzhou Evidence-Based Medicine Technology Co., Ltd. (hereinafter referred to as "Guangzhou EBM"), together with the Greater Bay Area Chapter of the CEIBS Healthcare Industry Association, visited the Alibaba Center in Guangzhou to co-host the "In-Depth Closed-Door Meeting on AI Transformation Implementation for Pharmaceutical Enterprises" in partnership with DingTalk Wukong and Maolu Academy. The event was designed to help healthcare companies break through barriers in compliance, data management, and cross-functional collaboration, enabling a systematic leap from individual productivity enhancement to organizational evolution.
2026-05-28
Embracing the AI Era, Empowering Organizational Evolution – Guangzhou EBM Management Team Attends AI Hands-On Training at Alibaba Center Guangzhou
Embracing the AI Era, Empowering Organizational Evolution – Guangzhou EBM Management Team Attends AI Hands-On Training at Alibaba Center Guangzhou
2026-05-18
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.
2026-10-16
The 4th Hengqin Forum on Guangdong-Hong Kong-Macao TCM Industry Integration
On October 15, 2026, the 4th Hengqin Forum for Guangdong-Hong Kong-Macao TCM Industry Integration was held in Hengqin, Zhuhai. Hosted by Guangdong Chinese Medicine Association and co-organized by multiple institutions, it gathered over 250 officials, experts and enterprise representatives. The forum interpreted proprietary Chinese medicine registration rules of Hong Kong and Macao. It included policy briefings, academic reports and on-site Q&A sessions to solve enterprises’ problems on cross-border registration and production, facilitating TCM industrial collaboration and global expansion in the Greater Bay Area.
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.
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.
2026-09-11
Guangzhou EBM Deputy GM Zhuo Jingxian Appointed to Two Committees of Guangdong Biomedical Innovation Technology Association
Guangzhou EBM Deputy GM Zhuo Jingxian was appointed Vice Chair of the TCM Research Committee and a member of the New Drug R&D and Clinical Committee of the Guangdong Biomedical Innovation Technology Association.
2026-09-11
From Pilot to Paradigm: Guangzhou EBM Drives "Research-Oriented Pharmacy RWS" into a New Stage of Quality Improvement and Expansion
The Xiaochaihu Granules research-oriented pharmacy RWS project has moved from pilot to expansion. Guangzhou EBM, as the core partner, built a GCP-like quality management system. As of August 31, 201 enrolled cases were completed, with plans to expand to 40 stores in 6 provinces by December.
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