With increasingly frequent exchanges and cooperation in the pharmaceutical and medical device sectors within the Guangdong-Hong Kong-Macao Greater Bay Area, the Centre for Pharmaceutical Regulatory Science (CPRS) at the University of Macau (UM) and the Asia Regulatory Professionals Association (ARPA) jointly launched the “2026 Guangdong-Hong Kong-Macao Greater Bay Area Regulatory Science Training Programme 3+1”. The initiative aims to deepen industry professionals’ understanding of the latest developments in pharmaceutical and medical device regulation in Macao, the Greater Bay Area, and internationally, while supporting regulatory capacity building in the ‘big health’ industry. The first workshop of the programme was successfully held at the UM on March 7.
The workshop brought together over 50 experts, scholars, government representatives, and industry professionals from mainland China, Hong Kong, and Macao, while also attracted around 90 online participants from the Greater Bay Area and beyond. Participants engaged in in-depth discussions and shared experiences on key topics, including the classification and regulations for pharmaceuticals, medical devices, traditional Chinese medicine and related products, as well as the strategies for accelerating product launch.
At the workshop, Hu Yuanjia, director of CPRS, announced the official launch of the “2026 Guangdong-Hong Kong-Macao Greater Bay Area Regulatory Science Training Programme 3+1”. He stated that the regulatory frameworks and systems for pharmaceuticals and medical devices in Guangdong, Hong Kong, and Macao each have their own unique characteristics, and he expressed hope that the programme would promote the coordinated regional development of regulatory science and explore practical approaches and cooperation opportunities in this field.
The workshop featured three presentations. Edward FW Yau, vice president of the Pharmaceutical Society of Hong Kong, introduced the classification principles for pharmaceuticals, medical devices, and traditional Chinese medicine products in Hong Kong, and elaborated on the current regulatory framework and development blueprint for traditional Chinese medicine in Hong Kong. Tony Yip, associate director of regulatory affairs, Asia Pacific at Grifols (HK), provided an overview of the latest updates on medical device regulations in the Asia-Pacific region. He highlighted the key aspects of post-market surveillance throughout the life cycle management of medical devices under the situation that imported products are dominated in the Hong Kong and Macao market. Jack Wong, founder of ARPA, shared strategies and feasible approaches for accelerating product launches.
Following the presentations, Carolina Ung Oi Lam, deputy director of CPRS, moderated a panel discussion along with Ansel Zhang and Carmen Ling from the Hong Kong LRP Panel (Regulatory Affairs Professional), and Terrenz Leung, regulatory affairs manager of Abbott Medical. The discussion covered topics including development of regulatory coordination and enhancement of regulatory capabilities in the Greater Bay Area. The experts unanimously agreed that post-market surveillance and product recall processes need to be prioritized, and that relevant systems and training should be strengthened. They also expressed hope that future workshops under the programme could further draw on the experiences of Hong Kong and other Asian countries to explore issues such as the translation of medical device research and development.
Distinguished guests attending the workshop included Lei Sai Ian, deputy director of the Pharmaceutical Administration Bureau of the Macao SAR Government; Iong Nin Fai, director of the Technology Department of the Economic and Technological Development Bureau of the Macao SAR Government; Chio Weng, director of Hospital Administration of the Conde S. Januário Hospital of the Health Bureau of the Macao SAR government; and Yuan Jing, associate professor of the Institute of Chinese Medical Sciences of UM.
As the first-of-its-kind training programme in the Greater Bay Area dedicated to capacity building in pharmaceutical and medical device regulation, the “2026 Guangdong-Hong Kong-Macao Greater Bay Area Regulatory Science Training Programme” consists of three workshops and one academic conference in 2026. Regulatory experts from within and outside the Greater Bay Area will be invited to share their professional experiences covering topics such as drug and medical device registration classification, regulatory frameworks and compliance requirements, quality and risk management of the total product life cycle, and good practices. These sessions aim to facilitate participants in mastering the latest knowledge on local, regional, and international regulations while enhancing their regulatory skills. The programme is also supported by the Institute of Chinese Medical Sciences at the UM and the Macao Society for Medicinal Administration.
UM holds the first workshop of 2026 Guangdong-Hong Kong-Macao Greater Bay Area Regulatory Science Training Programme 3+1
A group photo
Certificate presentation