DIA China Advisory Council Young Members
DIA China 2019

Safeguard Patients, Protect Your Business

Jesse Liu
AstraZeneca China


he blooming pharmaceutical market has brought about unprecedented business opportunities and challenges, especially for patients, industries, and government in China. As a result, the gaps between technology (especially technology that is expanding pharmaceutical industry capabilities), regulations, and unique or special circumstances specific to China, have been discussed a great deal during the past year. These conversations among representatives of regulatory and other government agencies, academic and other research institutions, hospitals, non-government organizations, and the pharmaceutical industry continued at DIA China 2019.

Key Takeaways

  • In pharmacovigilance, real world safety data is the hot topic. China has recently begun building active vigilance systems, many based on case studies from the EU and US, that use real world data to identify, evaluate, and manage the risk of healthcare products.
  • New knowledge technologies and methodologies are emerging as essential components of these new systems, including signal detection, Individual Case Safety Reports, and Risk Minimization Plans.
  • Lessons learned from implementing ICH E2B R3 (Electronic Transmission of Individual Case Safety Reports) in the EU are positively informing China’s activities in its own implementation.
  • Effective risk management is emerging as an essential component of post-market safety, and ensuring the safety of products on the market is good business for all stakeholders.

Post-Market Safety

As methodologies and technology platforms and systems for pharmacovigilance continue to evolve in China, the next step in this evolution has become using real world data to identify, evaluate, and manage the risks of marketed healthcare products. Many steps in this evolution will bring into China experiences shared at DIA China 2019 by academic and regulatory researchers from Asia, the EU, and the US, especially exploring signal detection in healthcare insurance databases and other electronic medical records. Using real world data to assess and validate risk minimization strategies and plans is also emerging in China based on experiences shared from other regions.

Pre-Market Safety

Pre-market clinical research is also being reshaped to meet this emphasis on safety and pharmacovigilance. China is now planning its implementation specifications for ICH E2B R3, Electronic Transmission of Individual Case Safety Reports, which will also be informed by experiences shared by the Clinical Trials Facilitation Group in the EU and other global stakeholders. Safety-related documents generated during clinical research—for example, internationally harmonized Development Safety Update Reports (DSURs) or regulatory reporting of Suspected Unexpected Serious Adverse Reactions (SUSARs)—are also essential components of China’s renewed regulatory focus on safety during the clinical stage.

Several leading innovative pharmaceutical companies in China have begun to submit their Investigational New Drug (IND) applications in overseas markets first. Pursuing these markets is not only sound business strategy; it has helped harmonize the quality of these applications with global expectations and standards.