From the newsletter
A company launching a drug, vaccine, diagnostic or any medical device today has to navigate dozens of different regulatory systems across Africa, since each country has its own regulations. A new World Health Organisation and the African Medicines Agency deal changes this by harmonising pharma regulatory systems to improve access to safe medicines.
Harmonisation allows for faster market access, lower compliance costs, larger markets, more attractive conditions for pharmaceutical manufacturing and greater confidence for investors. However, harmonising Africa's medicines market fully will likely take years, or up to a decade.
African countries have long preferred to do their own assessments, creating duplication that can add months or years before products reach patients. Regulation remains a national sovereignty issue with the biggest challenge being getting countries to trust each other.
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