Abstract: Objective To provide an important reference for drug marketing authorization holders and consignee to carry out pharmacovigilance commission. Methods From the perspective of drafters, the regulation is related with the drafting background, the status of post marketing pharmacovigilance Commission, guidelines and key points were introduced. Results and Conclusion The guidelines for the Pharmacovigilance delegation agreement (pilot version) has been officially released on June 4, 2020. As the first normative documentation on how to carry out pharmacovigilance delegation for drug marketing authorization holders in China in the new era, it aims to provide guide and enlightenment for relevant parties, and will be continuously adjusted and improved in practice.

Key words: pharmacovigilance, delegation agreement, drug marketing authorization holder, consignee