The National Agency for Food and Drug Administration and Control (NAFDAC) has assured Nigerians that medicines and vaccines provided beneath bilateral agreements with different nations will endure high quality and security checks, with their distribution monitored by a technology-driven monitoring system.
The company stated the United States-Nigeria government-backed medical merchandise beneath the well being cooperation settlement are meant to handle shortages of HIV/AIDS commodities following the exit of the United States Agency for International Development (USAID).
The Director-General of NAFDAC, Prof. Mojisola Adeyeye, in an announcement on Tuesday, stated it will retain its statutory accountability for regulating medicines, vaccines and diagnostic merchandise coming into the nation, together with these provided beneath the US-Nigeria authorities settlement.
She defined that merchandise manufactured within the United States and accredited by the US Food and Drug Administration (FDA) may gain advantage from expedited regulatory approval beneath its present regulatory reliance framework, given the stringent requirements utilized by the American regulator.
However, she careworn that merchandise not manufactured within the United States can be subjected to high quality, security and efficacy exams by NAFDAC.
“The USG-GoN MoU refers to NAFDAC’s present regulatory-reliance framework with US FDA the place merchandise manufactured within the USA, accredited by the very stringent US FDA rules are given expedited approval due to the stringency given to the method by US FDA.
“If the products donated are not manufactured in the USA, all of the products will be tested for quality, safety and efficacy by NAFDAC. That is, NAFDAC retains its responsibility for Nigeria’s own decision,” she stated.
Adeyeye added that regulatory reliance doesn’t take away its authority to judge purposes, examine merchandise and manufacturing services, conduct risk-based testing, launch vaccine batches the place required and perform post-market surveillance.
According to her, NAFDAC had beforehand subjected all COVID-19 vaccines provided to Nigeria through the pandemic to testing at its Vaccine, Biologics and Medical Devices Laboratory in Yaba, Lagos, regardless of their security declarations by the World Health Organisation.
She additionally disclosed that antiretroviral, tuberculosis and malaria medicines provided by the Global Fund are examined yearly by the company.
On the monitoring of merchandise after their entry into the nation, the DG stated NAFDAC would deploy its GS1 technology-driven Track and Trace system to watch the distribution of all medical merchandise provided beneath the US-Nigeria settlement.
She stated the system was used to watch the distribution of COVID-19 vaccines through the pandemic, with the data saved in its Traceability Information System (TIS).
Adeyeye added that the identical expertise was now getting used to watch non-COVID-19 vaccines, in addition to the availability chains for narcotics, maternal well being commodities and new child care merchandise.
NAFDAC stated the system would assist it monitor the motion and distribution of medical merchandise all through the availability chain.
The company reiterated its dedication to safeguarding public well being, stressing that it will proceed to discharge its regulatory obligations beneath the legislation.
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