On 7th May 2021, China’s National Medical Products Administration issued a new Pharmacovigilance Quality Management Practice/Standards (ie. China GvP) to regulate and guide the pharmacovigilance activities of drug marketing authorization holders and drug registration applicants. The Standards will be implemented on 1st December 2021.
Drug marketing authorization holders and drug registration applicants shall actively prepare for the implementation of the ” Pharmacovigilance Quality Management Practice/Standards”, establish and continuously improve the pharmacovigilance system as required, and standardize the development of pharmacovigilance activities.
Drug marketing authorization holders and drug registration applicants shall actively prepare for the implementation of the “Pharmacovigilance Quality Management Standards”, establish and continuously improve the pharmacovigilance system as required, and standardize the development of pharmacovigilance activities.
Drug marketing authorization holders are required to complete their registration in the National Adverse Drug Reaction Monitoring System within 60 days from the date of this announcement (ie. by 13th July 2021).
Link: 《药物警戒质量管理规范》的公告(2021年 第65号) Pharmacovigilance Quality Management Practice/Standards” (No. 65 of 2021): https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20210513151827179.html