Abstract: Objective To introduce the direct reporting system for adverse drug reactions by the marketing authorization holder (MAH), in terms of the policy background and specific functions. Methods The direct reporting system for adverse reactions by MAHs in China was illustrated by introducing such functions of the system as direct reporting of adverse drug reactions, risk data feedback, and product information maintenance. Results & Conclusion Since the direct reporting system for adverse reactions by MAHs in China was established, the regulators have been able to collect drug safety data of better quality from MAHs and promptly feedback the risk information to MAHs. The system can help MAHs to fulfill the main responsibilities. However, the application of E2B (R3)in the direct reporting system will face enormous challenges.

Key words: marketing authorization holder, adverse drug reaction, system, feedback