Cisema at the Regulatory Science for Pharmaceutical Innovation and Internationalization Conference

On April 28, 2024, the “Regulatory Science for Pharmaceutical Innovation and Internationalization Conference” took place in Macau, co-organized by the Macau Society for Medicinal Administration and the Centre for Pharmaceutical Regulatory Services at the University of Macau. This event drew together an esteemed panel of speakers and industry experts from across the globe, including representatives from regulatory authorities, academia, and industry. Among the speakers were Hamish King, CEO of Cisema, and Jacky Li, Senior Manager of Cisema. They were invited to present and share insights on the pathways for life science products from Hong Kong into the Greater Bay Area (GBA). Other panelist experts included:

• Yue Yang: Dean of School of Pharmaceutical Sciences at Tsinghua University and Director of Key Laboratory of Innovative Drug Research and Evaluation, National Medical Products Administration.
• Orin Chisholm: Associate Professor at The University of Sydney.
• Shan Wu: General Manager at AstraZeneca Hong Kong and Macau.
• Benjamin Kwong: Chairman of External Affairs Committee and Board of Governor and Council Member Fellow at The College of Pharmacy Practice, Hong Kong.
• Ling Su: Venture Partner at Lilly Asia Ventures and Chief Development Officer at Skyline Therapeutics.
• Yunfeng Lai: Associate Professor at Guangzhou University of Chinese Medicine.
• Hao Hu: Professor at Institute of Chinese Medical Sciences, University of Macau, and President of Macao Society for Medicinal Administration.
• Yuanjia Hu: Professor and Director of Centre for Pharmaceutical Regulatory Sciences at University of Macau.
• Ying Bian: Associate Professor and Assistant Director at University of Macau.
• Carolina Oi Lam Ung: Assistant Professor and Deputy Director of Centre for Pharmaceutical Regulatory Sciences at University of Macau.

The Regulatory Science for Pharmaceutical Innovation and Internationalization Conference served as a platform to delve into the complex landscape of China’s pharmaceutical regulation and its impact on innovation and global market expansion. Discussions covered various topics including regulatory strategies, drug development, market access, and international collaboration.

Key takeaways

Key insights from the conference include:

• Regulatory Harmonization: The need for harmonized regulatory standards across different regions to facilitate smoother market access and promote innovation.
• International Collaboration: Collaborative efforts between regulatory agencies, industry stakeholders, and academia are crucial for addressing global health challenges and accelerating drug development.
• Market Access: Streamlining regulatory processes is essential for ensuring timely access to innovative medicines while maintaining safety and efficacy standards.
• Innovation and R&D: Investing in research and development (R&D) and fostering innovation are vital for addressing unmet medical needs and improving patient outcomes.
• GBA Opportunities: Hong Kong’s and Macau’s strategic location within the GBA present significant opportunities for life science companies to tap into a vast market and access resources for research, development, and commercialization.

Further information

For those interested in bringing medical devices or pharmaceutical products from Hong Kong or Macau into the China Greater Bay Area, Cisema offers comprehensive regulatory consulting services to support your journey. Contact us today for assistance and guidance in navigating the regulatory landscape effectively.