PHARMACOVIGILANCE
Chiesi China has a system of pharmacovigilance in order to assume liability for our products (whether marketed or under clinical development) and to take appropriate actions when necessary. We ensure that all information relevant to patient safety and the risk-benefit ratio of our products is continuously evaluated and implemented. When important safety issues arise, if applicable, we promptly notify healthcare professionals, patients and regulatory agencies concerned in accordance with current legislation.
What is Pharmacovigilance?
Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem (Ref. World Health Organization, WHO. The importance of pharmacovigilance: safety monitoring of medicinal products, Genève, WHO, 2002).
In line with this general definition, the main objectives of pharmacovigilance in accordance with the applicable EU legislation are:
Pharmacovigilance is therefore an activity contributing to the protection of patient and public health.
What is an Adverse Drug Reaction?
A response to a medicinal product which is harmful and unintended (response in this context means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility).
Adverse reactions may arise from use of the product within or outside the terms of the marketing authorization or from occupational exposure. Conditions of use outside the marketing authorization include off-label use, overdose, misuse, abuse and medication errors.
Information on how to report an adverse drug reaction
If you are in China
Patients and healthcare professionals should refer to national regulations for reporting. You have the possibility to report directly to the Marketing Authorization Holder (MAH) of the drug that you suspect has caused the adverse reaction.
If you wish to notify directly to Chiesi China, please contact the Chiesi China pharmacovigilance team directly:
If you are outside China
Every country has laws governing the reporting of adverse drug reactions, therefore if you experience adverse drug reactions with our medicinal products, you are asked to contact local health personnel to rightly follow the notification procedure.
