WHO Certifies NAFDAC Fit to Regulate Production of COVID-19 Vaccine

Onyebuchi Ezigbo

The National Agency for Food and Drug Administration and Control (NAFDAC) said the World Health Organisation (WHO) had formally certified it as Maturity Level Three Regulatory agency. With this status, NAFDAC can now regulate and help to midwife the local production of vaccines, including the much-needed COVID-19 vaccines.

The agency stated that the approval was communicated to it yesterday.

While breaking the news at a media briefing in Abuja, Director General of NAFDAC, Professor Mojisola Adeyeye, said the agency and the Pharmaceutical Council of Nigeria scaled through many hurdles to achieve the feat.

Adeyeye stated, “I got the good news about 1am today and I quickly informed the closest people and some officials of the agency. We started the journey in January 2018, five weeks after my resumption. It was torturous, tasking and highly demanding.”

She said WHO’s global benchmarking was all about comparing regulatory agencies in the world.

Adeyeye explained, “We were told by WHO that we would meet 868 recommendations before we can get to Maturity Level 3.

“It sounded impossible but my directors stood by me all the way. Many others did all sacrifice to ensure we get here.

“In June 2019, WHO visited NAFDAC headquarters to commence the benchmarking process. Out of the 868 recommendations, we were able to meet over 600 recommendations and had 147 left, which were the most difficult ones at that time.

“We started working at it with town hall meetings and retreats. We made sure NAFDAC was on quality system which helped us to achieve the feat. In 2020, COVID-19 pandemic came and took a year out of our scheduled time.

“After the COVID-19 fever, we picked up from where we stopped in 2020. We revisited the 147 recommendations and commenced work on it.”

Adeyeye said the global benchmarking had eight standards, adding that NAFDAC is the third in Africa to meet the standard.

The NAFDAC boss said the next step was to attain Maturity Level 4, which would give greater quality assurance for drugs manufactured in Nigeria.

She explained that in July 2021, WHO met with the agency virtually, adding that NAFDAC was able to reduce the 147 recommendations to 33, which were the most difficult ones, including regulations.

By October 2021, according to Adeyeye, WHO officials returned for an update visit, and found that the agency had cleared all the recommendations.

She added, “In February, they returned for final inspection and they were glad that all items we submitted and claimed to have were intact. That was when they told us that we were successful, but we should not announce it until we see the letter, which came around 1am on Wednesday.

“NAFDAC is the third in Africa and one of the very few in the world. It is a great achievement for NAFDAC. The next step is Maturity Level 4. It will bring greater news for our pharmaceutical companies. If we attain Maturity Level 4, it means that any product NAFDAC approves can be traded globally.

“The Level 3 means that the quality of our drugs is better, clinical trials are better, guidelines are better, regulatory inspection, laboratory listing is better, market control, and other operations.”

Adeyeye also praised the wisdom of President Muhammadu Buhari, who she said intervened by giving NAFDAC N736 million to equip its laboratories.

She said, “When COVID-19 came, we got N4 billion to get equipment for vaccine lab. What Maturity Level 3 prepares us for now is manufacturing of vaccine through our manufacturers, which wouldn’t have been possible if we didn’t attend Maturity Level 3. That’s immediate benefit.

“We are building the vaccine lab in Oshodi, which will be ready by the middle of the year or early third quarter. The government supported us.”

Chairman of NAFDAC Board, Yusuf Suleiman, while expressing satisfaction with the development, said the implication of the certification was that Nigeria now had global acceptance for all that NAFDAC does.