Whether you are an investigator, trial sponsor or manufacturer of products or devices, compliance with safety reporting requirements to Chinese FDA has never been so critical on the heels of tightening regulations and increased scrutiny. In this short presentation, Deirdre McCarthy, Senior Benefit-Risk Management Director at Quintiles, discusses clinical trial safety reporting requirements for both sponsors and investigators, with a special segment on vaccine safety reporting. She also covers post-marketing requirements before finishing with an update on a recent medical device regulation in China.