New Pharmaceutical Vigilance in China

By December 1, 2021, according to the NMPA’s recent release on new Pharmacological Vigilance Quality Management Standards, Marketing Authorization Holders (MAHs) in China will have new pharmacological vigilance responsibilities. MAHs will need to have a dedicated pharmacovigilance team to deal with risk control issues, emergency drug incidents, etc. These MAH teams must provide specific assurances that clinical trials meet appropriate pharmacovigilant requirements too.