Proceedings: DIA China 2018

Safety and Pharmacovigilance

Xue Tang
Drug Safety Unit Regional Head (DRH),


orking together to address global health challenges is the key to effective safety monitoring and pharmacovigilance. With increasing volumes of shared data, the field of pharmacovigilance (PV), like many other healthcare areas, is exploding.

Sessions in the Safety and Pharmacovigilance theme focused on safety oversight in clinical trials, post-marketing safety surveillance, labelling across the product lifecycle, pharmacovigilance (PV) information systems, cardiovascular safety of anticancer drugs, and ICH E2 guideline updates.

Key Takeaways

Safety Oversight in Clinical Trials
It’s critical to standardize the management of important safety data during drug clinical trials to ensure the safety of subjects and to promote the internationalization of technical standards. The safety reporting and monitoring in clinical trial is much more important than before, in large part due to the following:

  • Project or product level safety oversight
  • Escalated safety-related issues
  • External expertise, such as via the Data Monitoring Committee

Post-Marketing Safety Surveillance
The Chinese PV system has developed quickly in recent years. China PV experts extensively discussed the development of a Chinese hospital sentinel site to support signal detection and safety evaluation in China.

Labeling Across Product Life Cycle
Labeling provides information that guides safe and effective use of drugs. It has been recognized as a key component of routine risk minimization measures and an integral part of a company’s global pharmacovigilance system. The development and maintenance of safety labeling across the product lifecycle involves science-based decision making processes and collective cross-functional activities. It is critical to ensure timely and consistent communication of safety information through product labeling.

PV Information Systems
Pharmacovigilance involves activities related to the detection, assessment, understanding, and prevention of adverse events or any other medicine-related problems. The National Drug Administration of China (CNDA, formerly CFDA) joined ICH last year and started to promote the implementation of ICH guidelines. It will significantly improve the quality of drug safety and surveillance in China. To meet the ICH guideline requirements, the China authority and industry have to use in-house or commercial PV information systems for adverse event collection, analysis, processing, and reporting.

Cardiovascular Safety of Anticancer Drugs
Advances in cancer treatments have led to improved survival of cancer patients, but their side effects have also contributed to an increase in morbidity and mortality. Among the most frequent side effects are cardiovascular diseases (CVDs), and there is a growing concern that these side effects may lead to premature morbidity and death among cancer survivors.