Answer： As the responsible party for drug vigilance, the holder shall bear the corresponding legal responsibility and establish corresponding mechanisms and process documents to ensure that the entrusted party's drug vigilance work complies with regulatory requirements. The "Quality Management Standards for Pharmacovigilance" put forward specific requirements for entrusted management. Holders may include, but are not limited to, the following aspects for entrusted management: 1) Conduct an internal review and selection of entrusted parties with corresponding pharmacovigilance conditions and capabilities according to the holders' internal processes. 2) Both parties sign a commission agreement. The Guiding Principles for Writing Pharmacovigilance Entrustment Agreements (Trial) also provide a reference for holders and entrusted parties to sign pharmacovigilance entrustment agreements. 3) During the execution of the entrusted matters by the entrusted party, the holder may supervise the entrusted party according to the supervision and management plan, and regularly audit the entrusted party to ensure that drug vigilance activities continue to meet the requirements. 4) According to Article 106 of the "Quality Management Standards for Pharmacovigilance", the commission of pharmacovigilance activities should be included in the main document of the pharmacovigilance system. 5) According to Article 114 of the "Quality Management Standards for Pharmacovigilance", manage the documents, records, and data generated from entrusted drug vigilance activities. (Refer to Article 15, Article 16, Article 17, Article 18, Article 106, and Article 114 of the Quality Management Standards for Pharmacovigilance)