NMPA released an annual report on ADR & ADE monitoring in China (the 2018 version). In this publication, we give a detailed overview of this report in English.
What is ADR?
ADR stands for Adverse Drug Reaction. According to WHO, an ADR is a response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease or for the modification of physiological function.
What is ADE?
ADE stands for Adverse Drug Event. That is, an ADE is an injury resulting from medical intervention related to a drug. This includes medication errors, adverse drug reactions, allergic reactions, and overdoses.
To sum up, from 1998 to 2018, China’s national ADR Monitoring has gone through the vicissitudes of two decades. During this period, NMPA focused on building an ADR monitoring system, improving relevant laws and regulations, expanding monitoring coverage, and establishing an early warning mechanism, based on risk prevention and control. Thus, ADR monitoring has developed rapidly.
Find out more about CR Medicon’s Pharmacovigilance service at https://en.crmedicon.com/platform/pharmacovigilance/.
Also subscribe to our CRO newsletter to receive current development, events, and reports like this from our industry:
CR Medicon (https://en.crmedicon.com) provides innovative pharma and biotech companies with comprehensive clinical development services, including drug registration, medical affairs, clinical operations, data management & statistical analysis, and biological sample analysis. We are China’s most well-known clinical CRO partner, for both domestic and overseas companies. CR Medicon team consists more than 200 full-time employees with clinical sites in both USA and China. Contact us at +1 (732) 624-9052 or email firstname.lastname@example.org.