Guangzhou Pharmaceutical Holdings' Baiyunshan Zhongyi Pharmaceutical has officially received the TGA certificate from the Therapeutic Goods Administration of Australia, successfully passing the recertification review and earning renewed international recognition for its quality management system and production control standards. This marks the second successful passage of the TGA review following the initial certification in 2021, representing another solid step forward in Guangzhou Pharmaceutical Holdings' internationalization journey.
The TGA certification stands as one of the highest-level accreditations in international pharmaceutical production quality management and serves as the premier passport for traditional Chinese medicine to enter overseas markets. The successful completion of this recertification review reflects the group's diligent implementation of national, provincial, and municipal requirements for TCM going global, while also exemplifying its sustained commitment to international expansion strategy.
As a vital component of Guangzhou Pharmaceutical Holdings' international footprint, BAIYUNSHAN PH (the English name for Baiyunshan Zhongyi Pharmaceutical) spent several months preparing for this TGA recertification. Facing increasingly stringent international pharmaceutical quality management requirements, the entire organization united in conducting comprehensive quality self-inspection activities aligned with the latest review standards. Leveraging internal and external audit resources, the company identified and addressed over 560 improvement tasks spanning 17 departments, covering key areas such as system documentation updates and enhanced computerized validation management. To ensure effective implementation of all improvement measures, multiple specialized seminars were convened to study and deploy solutions for critical issues identified during the review process, with weekly progress reports issued for each improvement project.
Multiple departments, including Quality Assurance, Production Technology, Quality Control, Equipment Engineering, and Digital Development, collaborated closely to implement meticulous management across every document, process, and site operation. During preparation, the team overcame regulatory differences and procedural conflicts, adapted to new review models, and conducted mock audits and live-streamed drills. Staff members worked around the clock to refine technical documentation and optimize processes, with frontline workers remaining dedicated to their posts and support departments providing full cooperation—every colleague contributed with utmost commitment.
From April 27 to 30, 2026, the TGA conducted a remote audit. Confronted with AI-assisted review and multi-site, multi-scenario live video inspections, the leadership of Baiyunshan Zhongyi Pharmaceutical went directly to the front lines, leading all departments in efficient coordination, rapidly providing compliant evidence chains, precisely responding to inquiries, and calmly managing unexpected situations. The company ultimately passed the review with high praise from the inspectors.
Currently, Guangzhou Pharmaceutical Holdings is targeting the overarching goal of "building another Guangyao" during the 15th Five-Year Plan period, adhering to the strategic path of "modernization, digitalization, technological advancement, and internationalization" as it races toward becoming a world-class enterprise. On the international front, the group has made internationalization a core focus throughout the construction of its "4+4+X" business development framework. Using Hong Kong and Macau as springboards for overseas expansion, the group has established an international company in Macau and built Macau's first GMP-standard TCM pharmaceutical plant, while also setting up the Guangyao Baiyunshan International R&D Center and Treasury Center in Hong Kong, forming an international innovation system characterized by "Hong Kong R&D, Greater Bay Area transformation, and global application."
Additionally, Guangzhou Pharmaceutical Holdings is strategically expanding into Southeast Asia, the Middle East, and South America as three key markets, promoting brands such as Wanglaoji, Baiyunshan, and Zhongyi Qixing across multiple countries. The Wanglaoji international brand identity "WALOVI" has already made its debut in several nations, with products reaching over 100 countries and regions worldwide. Zhongyi Qixing's first batch of TCM products has successfully registered in Vietnam, while flagship products including Angong Niuhuang Wan and Huatuo Zaizao Wan continue to expand their overseas presence. Through approaches such as "borrowing vessels to go to sea, building vessels to go to sea, and independent voyages," the group is advancing its internationalization strategy, continuously driving TCM from merely "going global" to truly "integrating globally," and striving to build an open cooperation ecosystem that connects global resources.
The successful passage of this TGA recertification has not only elevated the production quality management standards of Baiyunshan Zhongyi Pharmaceutical but also represents a significant achievement for Guangzhou Pharmaceutical Holdings' international strategy at the outset of the 15th Five-Year Plan period. Looking ahead, Guangzhou Pharmaceutical Holdings will continue anchoring its goal of "building another Guangyao," guided by the strategic principles of "modernization, digitalization, technological advancement, and internationalization," consistently benchmarking against international high standards, deepening quality commitment and regulatory compliance, continuously improving its quality management systems and product standards, supporting provincial and municipal efforts to establish a global hub for biomedical industry innovation, and accelerating along the path to becoming a world-class enterprise.