Надлежащая практика фармаконадзора
Good Pharmacovigilance Practice


Pharmacovigilance (abbreviated PV or PhV), also known as Drug Safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.[1] The etymological roots for the word "pharmacovigilance" are: pharmakon (Greek for drug) and vigilare (Latin for to keep watch). As such, pharmacovigilance heavily focuses on adverse drug reactions, or ADRs, which are defined as any response to a drug which is noxious and unintended, including lack of efficacy. (The condition, that thiss definition only applies with the doses normally used for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological function was excluded with the latest amendement of the applicable legislation.) Medication errors such as overdose, and misuse and abuse of a drug as well as drug exposure during pregnancy and breastfeeding, are also of interest (even without adverse event itself), because they may result in an ADR.

Information received from patients and healthcare providers, as well as other sources such as the medical literature, plays a critical role in providing the data necessary for pharmacovigilance to take place. In fact, in order to market or to test a pharmaceutical product in most countries, adverse event data received by the license holder (usually a pharmaceutical company) must be submitted to the local drug regulatory authority. (See Adverse Event Reporting below.)

Ultimately, pharmacovigilance is concerned with identifying the hazards associated with pharmaceutical products and with minimising the risk of any harm that may come to patients.


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КОМИССИЯ применения Регламента (ЕС) № 520/2012
из 19 Июня 2012
о выполнении фармаконадзора мероприятий, предусмотренной в Регламенте (ЕС) № 726/2004 Европейского парламента и Совета и Директивы 2001/83/ЕС Европейского Парламента и Совета
of 19 June 2012
on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council