With the Chinese regulatory agency officially joining the ICH in 2017, the implementation of a number of ICH guidelines in China has been scheduled. Especially after China joined the ICH Management Committee this June, the China National Medical Product Administration (NMPA) has accelerated its implementation progress among both MNCs and local Chinese enterprises. On July 30, 2018, the “E2B (R2) An Implementation Guide for Electronic Transmission of Individual Case Safety Reports” was issued at the website of the Center for Drug Evaluation, which was another important milestone in E2B implementation in China. The implementation plan for E2B (R3) will be followed by an intensive efforts towards the goals of May 1, 2019 (pre-market) and July 1 (post-market).

Is E2B only a guideline for authorities and companies to establish drug safety data system and to quickly report individual case safety report through electronic transmission? What does authority do with this data? How to monitor risk and control risk? What is the process of changes in the strategy for system building and operational processes? How will the internal processes for submitting reports and databases setting by companies (especially multinational pharmaceutical companies) meet Chinese regulatory requirements, and at the same time, be consistent with the international standards? These are the opportunities and challenges in front of all PV personnel engaged in pharmacovigilance.

This course will invite Japanese and European authority officers with years’ experience in E2B implementation and share the change to overview of pharmacovigilance system and E2B implementation status in Japan, Europe and UK, and will reveal the overall considerations from authorities in E2B implementation in China. The course will study the experience of the E2B implementation in Japan and the implementation and information systems in Europe, and explore from the perspectives of pharm companies the opportunities and challenges of E2B implementation in China.