戻る Agenda
How to Fulfill Pharmacovigilance Responsibilities under China’s MAH System - Part 1
Session Chair(s)
Lynn Zhou, MD
Associate Director, International Pharmacovigilance Coordinator
Sanofi, China
The MAH system has been piloted in ten provinces and cities for 4 years. With the official launch of the new version of the Drug Administration Law, MAH’s responsibilities for all aspects of the drug life cycle are gradually being implemented. The new version of the “Drug Administration Law” first time mentioned the concept of pharmacovigilance system which is upgraded compared with the previous concept on “adverse reaction reporting system”. GVP is also ready to come out, how should MAH fulfill all the PV duties as of MAH? The seminar in the first and second half of the PV session will help audience to better understand how does MAH fulfill its pharmacovigilance responsibility covering the entire product life cycle in China under the new version of the “Drug Administration Law”, the PV requirements on MAH from European drug regulatory agencies, the experience of China’s MAH system pilots, and the perspectives from Provincial drug regulatory agencies on MAH inspections, e.g. focused areas of MAH inspection, preparation of MAH annual reports/PV annual reports, and discussions about the differences between annual reports vs PSMF. We hope that our session will help audience to have a clear understanding of existing regulations on MAH’s pharmacovigilance responsibilities and how to fulfill these responsibilities.