The Rwandan Food and Drug Authority (Rwanda FDA) gives an extra month to importers of drugs not yet registered. The decision was taken on Thursday 24 December.
The deadline for registering all drugs on the market in Rwanda had been set at 31 December 2020. About 2000 would already be registered on a list of 6000 imported products. Rwanda FDA had threatened importers to stop allowing unregistered drugs into the country from January 2021. A shortage of around 4,000 products was inevitable.
“To avoid a shortage of drugs, Rwanda FDA gives importers an extra month to provide information on the difficulties encountered,” said Alex Gisagara, director of the Food and Drug Inspection and Control Department.
“We want to know if there are any imported products that are not represented in the country or if there is another problem,” says director Alex Gisagara.
The major difficulty revealed by the importers of the drug products is the cost required by Rwanda FDA. Before registering a product, you have to pay US$5,000 if the product is to be imported to a pharmaceutical laboratory in Asia, US$7,000 in the US, US$3,000 in one of the East African countries and US$4,000 in the rest of Africa.
This amount is used to cover the Rwanda FDA’s good practice inspection at one of the pharmaceutical companies abroad. Once this work is completed, it takes US$1,200 to register each product.
“That’s the price of this service. In all institutions, services rendered to clients are paid for,” says Alex Gisagara.
For the past two years, the Rwandan Food and Drug Authority (Rwanda FDA) has been asking drug importers to register all drug products on the market.
The first deadline ended in June 2019. Rwanda FDA has granted an extension of 6 months (December 2019). This too has not been respected. They pushed it to June 2020. The expected result was not achieved. The last deadline had been set for 31 December 2020.
Gérard Rugambwa
