We provide professional regulatory services for traditional Chinese medicines, chemical drugs, biological products, and medical devices, facilitating drug development and shortening time to market. Throughout the product registration process, our extensive practical experience enables us to precisely grasp the key points of product registration and fully understand the specific requirements of regulatory authorities in different regions for product submission dossiers. We maintain effective two-way communication with both clients and government regulatory agencies from multiple levels and aspects, including procedural regulations, regulatory requirements, and technical compliance, ensuring the rapid advancement of projects.
Guangzhou Evidence-Based Pharmaceutical Technology Co., Ltd. has long been deeply engaged in the registration of traditional Chinese medicines from Hong Kong and Macao for the mainland Chinese market, with extensive successful experience in simplified registration for Hong Kong and Macao already-marketed TCM products in the mainland, including Compound Safflower Oil (National Drug Approval No. ZCGD20240002) and Qufeng Zhangbo Oil (National Drug Approval No. ZCGD20240001). Leveraging the policies of the NMPA Greater Bay Area Sub-Center and the territorial review and inspection policies of the Guangdong Provincial Drug Administration, we provide one-stop full-process registration and submission services for Hong Kong and Macao local TCM manufacturers in the simplified registration of Hong Kong and Macao topical/oral proprietary Chinese medicines in the Greater Bay Area, opening up the channel for time-honored Hong Kong and Macao TCM products to legally enter the mainland market.
Deeply engaged in cross-border pharmaceutical compliance registration services, we maintain long-term in-depth collaborations with local senior proprietary Chinese medicine registration experts and licensed TCM consultant teams in Hong Kong and Macao. With comprehensive familiarity with the full set of review rules of the Chinese Medicine Regulatory Office of Hong Kong and the Macao Pharmaceutical Administration Bureau, we provide full-process agency services for HKC registration of proprietary Chinese medicines in Hong Kong and registration of proprietary Chinese medicines in Macao for mainland TCM R&D and manufacturing enterprises, offering one-stop solutions to the compliance challenges faced by mainland enterprises in entering the Hong Kong and Macao markets.
With a dedicated team specializing in domestic regulatory submissions, we provide comprehensive import and full-lifecycle registration agency services for overseas pharmaceutical companies and drug manufacturers from Hong Kong, Macao, and Taiwan, covering traditional Chinese medicines, chemical drugs, biological products, and medical devices. We offer one-stop submission services for the entire process of import new drugs, generic drugs, re-registration of originator products, and import supplementary applications.
Providing full-process services for traditional Chinese medicine new drug clinical trial applications. Successful cases include: Pien Tze Huang Capsules (primary liver cancer), KD-1 Capsules (COVID-19), Jinzhen Oral Liquid (pediatric viral pneumonia), LBZ-18 Oral Emulsion (cancer-related fatigue), and others.
Core experts have extensive experience in over 20 Hong Kong proprietary Chinese medicine registrations.
Collaboration among three professional institutions covering pharmacy, toxicology, and testing ensures comprehensive support.
Maintaining efficient communication with the Hong Kong Department of Health and the Macao Pharmaceutical Administration Bureau.
Real-time grasp of the latest regulatory trends.
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.
