Pharmacovigilance Duties of Marketing Authorization Holders under of New Drug Administration Law of the People's Republic of China

doi:10.19803/j.1672-8629.2020.10.07

Abstract

Abstract: Objective To sort out pharmacovigilance duties of MAH according to the new Drug Administration Law of the People's Republic of China. Methods Use the literature induction method to sort out and summarize the relevant content of legal regulations in China. Results The main pharmacovigilance duties of MAA/MAH for applicants and holders in China are to establish and improve the pharmacovigilance system and carry out specific activities such as monitoring, identification, evaluation and control. Suggestions China should improve the legal system of pharmacovigilance, to link up different laws and regulations, provide detailed guidelines and carry out accurate guidance, urge the MAH to effectively carry out pharmacovigilance activities, and rationally design the route of supervision and control, strengthen supervision and promote the implementation of pharmacovigilance system.

Key words: pharmacovigilance, pharmaceutical administration law, holder of drug marketing authorization, statutory duties

CLC Number:

R951

SUN Jun, WANG Jiayu, LIU Pengcheng, YU Dandan, WANG Minjiao, SHEN Mengqiu. Pharmacovigilance Duties of Marketing Authorization Holders under of New Drug Administration Law of the People's Republic of China[J]. Chinese Journal of Pharmacovigilance, 2020, 17(10): 681-687.

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