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Regulatory Harmonization Makes Big Strides In Africa

 
• By Ian Schofield

Last month a drug for the prevention of uterine haemorrhage became the first product to be approved under a novel scheme designed to speed up access to medicines in low and middle-income countries, particularly those in sub-Saharan Africa. 

Cogs

Ferring Pharmaceuticals AS’s heat-stable formulation of carbocetin was authorized in Switzerland using the new Marketing Authorization for Global Health Products (MAGHP) procedure. It will now undergo rapid assessments in seven participating African countries, based on the Swiss approval dossier.

The new formulation, which was added to the World Health Organization’s Essential Medicines List (EML) last year, was developed by...

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