China Pharmacovigilance (PV) regulatory system opened a new chapter in 2019 when it included the new provision of“Establishing Pharmacovigilance System” in “China Drug Administration Law”. Soon after, National Medical Products Administration (NMPA) in December 2020 drafted“Good Pharmacovigilance Practice” (GVP) to clarify and standardize the obligations and responsibilities of MAHs and Sponsors in Pharmacovigilance (abbreviated as “PV”).
Accestra Consulting provides comprehensive pharmacovigilance services to ensure compliance with China Good Pharmacovigilance Practice (GVP) according to NMPA requirements for post-marketing authorization. Our services align and reference International Conference on Harmonisation (ICH), FDA and EMA standards. These services include but not limited to the following below: