From the time humans begin taking an investigational new drug, pharmacovigilance measures play a critical role in every phase of a product’s lifecycle. However, understanding pharmacovigilance requirements can be daunting even for seasoned industry pros. This overview will answer all the questions you ever wanted to know about pharmacovigilance, but were afraid to ask.  What is pharmacovigilance? Pharmacovigilance, sometimes shortened to “PV,” is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications and biologics.  What are the basic components of a pharmacovigilance strategy? A robust pharmacovigilance strategy requires…

Regulators decide to authorise medicines after assessing their benefits and risks based on the results of clinical trials. Only medicines whose benefits have been shown to be greater than their risks can reach the market. This ensures that patients can access the treatments they need without being exposed to unacceptable side effects. Clinical trials involve a relatively small number of patients for a limited period of time. Patients in clinical trials are carefully selected and followed up very closely under controlled conditions. In a real-life setting, a larger number of patients will use the medicine; they may have other diseases;…

The PRAC maintains a list of medicines under additional monitoring in the EU, which it updates every month. For more information, see the list of medicines under additional monitoring. Additional monitoring status may be assigned to a medicine when it is approved for the first time or at any time during its life cycle. A medicine remains under additional monitoring for 5 years or until the PRAC decides to remove it from the list. There may be a delay between the Agency's decision to add or remove a medicine from this list and the time when the updated package leaflet…

The European Union (EU) has introduced a new process to label medicines that are being monitored particularly closely by regulatory authorities. These medicines are described as being under 'additional monitoring'. The concept of additional monitoring was introduced by the new EU laws on the safety-monitoring of medicines, the pharmacovigilance legislation, which started to come into effect in July 2012. Medicines under additional monitoring have a black inverted triangle displayed in the package leaflet and in the information for healthcare professionals (called the summary of product characteristics) together with a short text explaining what it means. The black triangle will be…