“We are delighted to announce a new partnership with the Bill & Melinda Gates Foundation and the World Health Organisation that aims to extensively improve the safety monitoring of medicines in low and middle-income countries (LMIC).

New medicines and vaccines, for diseases such as malaria and HIV, may be introduced for the first time in LMIC’s where there are weak or no regulatory systems in place for effective safety monitoring. These new treatments have been developed with urgent public health needs in mind and therefore the need to gather and analyse information quickly on their safety and effectiveness is important. The healthcare and regulatory systems in these settings may often lack the tools, training and capacity to operate a robust safety monitoring system. Whilst great progress has been made with many of LMIC’s now involved as members of the World Health Organization Program for International Drug Monitoring, the experience in collecting, assessing and acting on adverse reaction data, and risk management planning is limited.

Without an effective system, public health programs are at risk and patients may be affected, should they suffer from adverse drug reactions (ADRs) which are not promptly identified and treated. This can consequently undermine the program and result in a loss of trust in the product or a vaccine. Ultimately, this may lead to lower uptake and therefore, the disease not being effectively treated.

WHO and the Gates Foundation have launched ‘Project Smart Safety Surveillance’ (also known as Project 3-S) to help LMIC’s identify, assess, and adequately manage the risks associated with new products. MHRA will be joining this initiative to bring regulatory expertise to the project. This will be for a 3-year period where it is intended to run three pilot exercises in different LMIC settings.”

 

Medicines & Healthcare products Regulatory Agency is the UK government agency that signs off the vaccine as safe.