• Deploys track-and-trace expertise to watch distribution of medicines and vaccines nationwide
Sunday Ehigiator
The National Agency for Food and Drug Administration and Control (NAFDAC) has assured Nigerians that medical merchandise provided beneath agreements between the Nigerian and United States governments will bear acceptable regulatory checks, with their distribution monitored by a technology-driven monitoring system.
The company stated the United States-Nigeria governments (USG-GoN) medical merchandise have been meant to handle gaps in HIV/AIDS remedy created by the exit of the United States Agency for International Development (USAID).
In an announcement yesterday, signed by its Director General, Prof. Mojisola Adeyeye, NAFDAC stated it retained its statutory accountability for regulating medicines, vaccines and diagnostic merchandise getting into Nigeria, stressing that regulatory cooperation with international companies wouldn’t compromise its mandate.
“As the Agency with the mandate to safeguard the health of Nigerians, NAFDAC will NOT fail to carry out this responsibility as enshrined in the mandate,” the company stated.
NAFDAC defined that the memorandum of understanding between the US and Nigerian governments referred to its present regulatory-reliance framework with the US Food and Drug Administration (FDA), beneath which merchandise manufactured within the United States and permitted by the regulator may benefit from expedited approval.
The company, nevertheless, clarified that merchandise not manufactured within the US could be examined by NAFDAC for high quality, security and efficacy.
“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.”
According to the company, regulatory reliance reduces pointless duplication and accelerates entry to quality-assured merchandise with out eradicating its authority to judge purposes, examine merchandise and amenities, conduct risk-based testing, launch vaccine tons and undertake post-market surveillance the place essential.
NAFDAC cited its regulatory actions in the course of the COVID-19 pandemic as proof of its dedication to defending public well being.
“ALL COVID-19 vaccines given to Nigeria during the pandemic were tested at our Yaba Vaccine, Biologics and Medical Devices laboratory in Yaba despite the fact they have been declared safe by the World Health Organization,” it stated.
The company additionally disclosed that every one antiretroviral, tuberculosis and malaria medication provided by the Global Fund have been examined yearly.
On monitoring the distribution of medical merchandise, NAFDAC stated it had deployed the GS1 technology-driven Track and Trace system to watch the motion of COVID-19 vaccines distributed throughout Nigeria in the course of the pandemic.
It defined that the distribution data have been maintained in its Traceability Information System (TIS), which was now getting used to watch non-COVID-19 vaccines.
The company added that it had began utilizing the system to watch the availability chain and distribution of narcotics, in addition to maternal, new child and youngster well being commodities.
“NAFDAC will use the same GS1 technology-driven Track and Trace system to monitor ALL medical products that come into the country under the USG-GoN Agreement,” the assertion added.
The company stated the system would allow it to watch the distribution of medical merchandise beneath the settlement and reinforce oversight of their motion by the nation’s provide chain.
NAFDAC reiterated its dedication to making sure that medicines and vaccines getting into Nigeria meet relevant regulatory necessities, regardless of the preparations beneath which they’re provided.
