- Keywords > active pharmacovigilance surveillance
- Keywords > adverse drug reactions (ADRs)
- Keywords > efficacy and safety of medicines
- Keywords > medicines regulation
- Keywords > national reporting systems - adverse reactions to medicines
- Keywords > pharmacovigilance - capacity building
- Keywords > pharmacovigilance reporting system
- Keywords > post marketing surveillance
- Keywords > regulatory harmonization
- Keywords > WHO International Drug Monitoring Programme
(2018; 6 pages)
Access to medicines and vaccines in low- and middle-income countries (LMICs) has improved in the past two decades. However there has not been a proportionate improvement in pharmacovigilance infrastructure and activities to monitor adverse events and address safety issues. This is of particular concern as there is a sizeable pipeline of novel products to be introduced in LMICs. These products are developed in well-resourced settings, with baseline safety data that may not be entirely applicable to the population and context of target countries.
Safety monitoring of medicines is essential to protect people from harm. The lack of functional pharmacovigilance structures could become a barrier to the introduction of these products to some LMICs and could seriously undermine the treatment options available to patients. A new project proposes to strengthen pharmacovigilance capacity in LMICs and, in the long-term, establish end-to-end safety surveillance of products from their clinical development to the postmarket stages. In its current phase the project focuses on selected medicines and vaccines that will be introduced in the next few years.