Pharmacovigilance, the science of detecting, assessing and preventing adverse drug reactions, is essential to public health. In Africa and the Middle East, regulations have developed over recent years and decades, with increasing integration into regional and international networks.
- Concerning the Maghreb and Middle East countries:
In Tunisia, the National Pharmacovigilance Centre (CNPV) was created under the supervision of the Ministry of Public Health in 1984 by Law 84-84. Recently, Tunisia has developed more detailed regulations and guidelines for Good Pharmacovigilance Practice.
In Morocco, the Anti-Poison and Pharmacovigilance Center (CAPM) was created in 1989.
In Algeria, the National Centre for Pharmacovigilance and Materiovigilance (CNPM) was created in 1998.
In Egypt, pharmacovigilance is managed by the Egyptian Pharmacovigilance Center (EPVC).
In Iraq, the Iraqi Pharmacovigilance Center (IPhvC) was created in 2010 under the Ministry of Health.
In Jordan, the Jordanian Pharmacovigilance Center (JPC) has been working in collaboration with the Food and Drug Administration (FDA) since 2001.
In 2003, the government of Saudi Arabia established the SFDA and in 2009 a separate unit called the National Pharmacovigilance Center (NPC) was established.
Only 45% of Arab countries are official members of the World Health Organization’s (WHO) Collaborating Centre for International Medicines Surveillance.
Countries such as Morocco, Tunisia, Saudi Arabia, Egypt and Jordan are considered advanced in terms of pharmacovigilance, while other countries are only in the early stages of implementing and developing pharmacovigilance for the majority of health system activities, including pharmacovigilance.
Given the diversity of health systems and the development of pharmacovigilance centres in the Maghreb and the Middle East, a guide has proven to be essential for the uniformity and harmonization of pharmacovigilance practices and regulations between Arab countries.
The Guideline on good Pharmacovigilance practices (GVP) For Arab Countries has been developed on the basis of the European Good Pharmacovigilance Practices (EU GVP) and the ICH, and is considered an “ideal model” for Arab countries, which can add other local specificities.
- Concerning other African countries:
In Central Africa, the Democratic Republic of Congo, the National Pharmacovigilance System has been operational since 2009, when the National Pharmacovigilance Centre (CNPV) was created. Since 2010, the CNPV has been an effective member of the WHO’s international pharmacovigilance center, the Uppsala Monitoring Centre (UMC).
In West Africa in Burkina Faso, since 2008, a national pharmacovigilance service has been created within the Directorate General of Pharmacy, Medicines and Laboratories (DGPML).
In Côte d’Ivoire, pharmacovigilance is supported by the AIRP (Ivorian Pharmaceutical Regulatory Authority), and a pharmacovigilance centre is being formed.
The Pharmacovigilance Centre in Senegal is under the aegis of the Senegalese Pharmaceutical Regulatory Agency (ARP).
The National Pharmacovigilance Centre in Nigeria was established under the World Health Organization’s (WHO) International Drug Surveillance Programme in 2004.
The National Pharmacovigilance Centre in Ghana is managed by the Food and Drugs Authority (FDA). Ghana joined the WHO’s International Drug Monitoring Programme in November 2001.
In Mali, the National Reference Centre for Pharmacovigilance (CNRP), created within the National Centre for Disease Control Support (CNAM) in 2011, is responsible for this activity.
In Togo, the first formal pharmacovigilance activity was noted in December 2006.
In East Africa, Uganda, under the National Drug Authority (NDA), the Uganda National Pharmacovigilance Centre was established in 1993. In 2020, the National Drug Authority in Uganda is in the process of creating a mobile application called “Med Safety”, in order to facilitate the collection of information.
In South Africa, pharmacovigilance has been a function of the Medicines Control Council (MCC) since 1997.
Several other countries have initiated the establishment and organization of national pharmacovigilance systems. However, other actions and resources are necessary in order to generalize effective pharmacovigilance monitoring in all African countries.