On Dec 1, 2020, National Medical Products Administration (NMPA) issued the draft Good Pharmacovigilance Practices (GVP) for public consultation, openly circulating for comments from the public until Dec 18, 2020.
The Pharmaceutical Administration Law of the People’s Republic of China has came into force on Dec 1, 2019. This regulation specifies that China will establish a pharmacovigilance system which identifies, monitors, evaluates and controls adverse drug reactions and other adverse reactions related to drug usage. It also clearly implements the Marketing Authorization Holder (MAH) for drug administration: the holder shall be responsible for the monitoring, reporting, and handling of adverse drug reactions.
The draft GVP fully adopts the requirements of the ICH guidelines, including the reporting scope and time frame of adverse drug reactions, as well as the information collection source, etc. It also conforms with the ICH guidelines in terms of technical requirements and standards. In addition, the draft GVP also uses the years of experience of other international organizations and countries like Europe, the United States, Japan for reference. This includes the signal detection requirements of Council for International Organizations of Medical Sciences (CIOMS), the pharmacovigilance system and master file requirements of the EU, requirements regarding the enhancement of passive surveillance in Japan and EU, etc.
The draft GVP also indicates that under China’s Marketing Authorization Holder (MAH) system, pharmacovigilance can also be implemented through the outsourcing way. Due to the high technicality of pharmacovigilance, entrusting some PV work such as spontaneous report collection or scientific literature searches to a third party service provider not only saves the cost of time and labor of MAH, but also effectively ensures the level of pharmacovigilance for pharmaceutical enterprises with weaker capabilities.