Best practices for harmonizing the regulation of medicines in Africa

What is it about?

When individual countries require medicines manufacturers to submit different applications and apply different requirements in order to sell their medicines, it can significantly delay access to those products. In Africa, the availability of important drugs is often delayed by years, in part because of this lack of harmonization. In response to this problem, a number of regional economic communities in Africa (i.e., groups of nearby countries) have created initiatives to harmonize the way that medicines are regulated, with the goal of making it easier for manufacturers to apply to sell safe, effective medicines of ensured quality within multiple countries at once. In this study, we interviewed staff from four of these initiatives to identify best practices for regulatory harmonization, so that these practices could be shared with regional initiatives within and outside Africa. We also interviewed staff at medicines manufacturers that had worked with these initiatives, to get their input on best practices in regional harmonization.

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Photo by Towfiqu barbhuiya on Unsplash

Photo by Towfiqu barbhuiya on Unsplash

Why is it important?

This work is important because by identifying and implementing best practices in harmonizing the regulation of medicines, regional initiatives can minimize the time it takes for people living within their borders to gain access to life-saving products. Better access to medicines means more people will get to live healthy lives.