Pharmacovigilance / Drug Safety Defined

What is it?

According to ICH E2D, an adverse event (AE) is any untoward medical occurrence in a patient administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (for example, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. According to Food and Drug Regulations, an adverse drug reaction (ADR) is a noxious and unintended response to a drug, which occurs at doses normally used or tested for the diagnosis, treatment or prevention of a disease or the modification of an organic function.  In some countries, ADRs rank among the top 10 leading causes of mortality. Most of the adverse drug reactions are preventable.

Pharmacovigilance (PV), as defined by World Health Organization (WHO), is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug related problems.  PV activities include: collection of adverse reactions related to the drug, analysis of the data, reporting of the data, signal detection and evaluation, preparation of safety reports, monitoring of worldwide literature, ensuring regulatory compliance and meeting safety timelines.  The term Drug Safety is sometimes used interchangeably with PV.

Why is it necessary?

Since most adverse drug reactions are preventable, identifying and monitoring of adverse events play an important role in ensuring that health professionals, together with the patient, have enough information to make a decision when it comes to choosing a drug for treatment.

How can Regxia help?

• Regxia has a robust pharmacovigilance system that ensures that your marketed product is in compliance with international Food and Drug Regulations.

• Regxia’s PV team can help in preparation and submission of safety reports in PSUR, PBRER or PADER format.

• Regxia’s PV team can help in detection, identification and processing of signals.

• Regxia’s PV team can prepare your company for upcoming PV Inspections and fulfil your regular self-inspection requirements.

Would you like to know further how Regxia can help you in Drug Safety Monitoring? Contact us here.