Pharmacovigilance is the science related to the collection, detection, assessment, monitoring, and prevention of adverse reactions with pharmaceutical products, whether potential or proven.
It is governed by rules of good practice, laws, directives and decrees. It is based on :

  • spontaneous notification of adverse effects by doctors, health personnel or the patient.
  • recording and evaluation of this data.
  • setting-up of studies and investigations of adverse effects.
  • establishment and monitoring of a rigorously developed RMP (risk management plan).
  • assessment of the safety profile of the use of the drug based on the collected information.
  • taking corrective measures, ranging from simple corrections to a withdrawal of the batch if necessary.
  • communication and dissemination of information relating to job security.
  • participation in the public health policy for the prevention of iatrogenic drugs.

The risk management plan (RMP), as a part of the legislative framework, was established by the Tunisian NCPV (National Center of PharmacoVigilancy) to be part of the Marketing Authorization (AMM) file of a drug.
A RMP is required for all new drugs submitted for registration. It can also be implemented in the post-marketing phase if significant changes occur (new indication, new dosage, new route of administration, new manufacturing process) or if a significant risk has been identified.
It allows :

  • a better characterization and/or prevention of the risks associated with a drug
  • to update the data available at the time of commercialization
  • to monitor the actual conditions of use

It involves, when necessary, additional measures to routine activities, such as :

  • an active pharmacovigilance, reinforced on some of the risks highlighted in the RMP.
  • a post-marketing safety studies and/or use studies.
  • an Additional Risk Reduction Measures (ARRM) (information documents for healthcare professionals or patients).

The PBRER (Periodic Benefit-Risk Evaluation Report) also known as the PSUR (Periodic Safety Update Report) is a periodic assessment of the risk-benefit balance of the product. It is submitted yearly by the marketing authorization titular. The PBRER provides an analysis of the safety, efficacy, and effectiveness of the product over its lifecycle.
The format and content of the PBRER required in Tunisia as well as in Europe and the Arab world are those of the PBRER described in the ICH-E2C (R2) guideline.
In Tunisia, an abbreviated PSUR can be used in the case of generic drugs.