Pharmacovigilance has been defined by the World Health Organization as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. This Guideline of the Egyptian Pharmacovigilance Center (EPVC) has been developed to bring guidance on the requirements, procedures, roles and activities in the field of human Pharmacovigilance, for Marketing Authorization Holders (MAHs) of medicinal products for human use .

This guidance describes the respective obligations of the MAH and (their local representative agent in Egypt in case imported products) to set up a system for Pharmacovigilance in order to collect, collate and evaluate information about suspected adverse reactions. All relevant information should be shared between EPVC and the MAH, in order to allow all parties involved in pharmacovigilance activities to assume their obligations and responsibilities.

The regulatory requirements stated in this guideline are based mainly on the European Medicine Evaluation Agency (EMEA) guidelines and International Conference for Harmonization (ICH).

The ultimate goal is to ensure that the MAHs are fulfilling their principal role in the safety monitoring of their medical products for human use, hence enhance efforts in ensuring that safe, efficacious, and quality medicines are made available for all Egyptians.

It should be noted, as with all guidance documents in rapidly evolving technical areas, that this guidance is intended to be regularly reviewed and updated.