NAFDAC charges pharmaceutical companies on quality products for the benefit of the AFcFTA

Nigerian pharmaceutical companies must be ready to market their products across the continent with quality products that can be approved in the various countries through continental trust among regulators, the chief executive of the National Agency for Administration has said. and Food Control (NAFDAC), Professor Mojisola Adeyeye. said.

Prof Mojisola Adeyeye said this was highlighted today because of the African Free Trade Agreement (AfcFTA) which allows for free trade between African countries.

Speaking on ”From Green to Gold: Operational Realities in the 21st Century on the occasion of the 50th anniversary of Daily-Need Industries Limited” in Lagos, the NAFDAC boss pointed out that research and development ( R&D) are an important creativity and innovation that several companies are going to need to be integrated into the manufacturing environment.

Professor Mojisola Adeyeye, in a statement signed by NAFDAC Resident Media Consultant, Sayo Akintola, in Lagos on Sunday, said it will encourage research and clinical trials of new molecules, immunomodulators, complementary alternative medicines, especially for certain non-communicable diseases. diseases such as cancer, diabetes, among others.

Professor Mojisola Adeyeye pointed out that an innovation that the COVID-19 pandemic has taught us in Nigeria is long embracing the manufacture of vaccines, active pharmaceutical ingredients and excipients, stressing that until we have at minus five start-up companies making these pharmaceutical ingredients, and one or two companies making vaccines, Nigeria will remain insecure.

Knowing of the progress Daily-Need has made over the past 50 years, she said she believes that diligence, strategic leadership and responding to challenges through the improvement of manufacturing facilities with continuous quality control will generate a future where innovation and creativity will be embraced for drug safety, health security and, eventually, universal health coverage.

She said Daily-Need had sown a seed using just one product, penicillin ointment, and the company had grown to more than 20 product categories. The Bible says at Ecclesiastes 11:6: “Sow your seed in the morning, and in the evening let your hands not be idle, for you do not know which will succeed, this or that, or whether both will succeed equally.

Professor Mojisola Adeyeye said it highlights the operational realities of any century, especially the 21st century, as she identified the sower, the soil and the creativity and innovation of the sower as the three operational realities pharmaceutical development.

She described the sower as the founder, general manager, leader, etc. ; The question can be asked, what are the characteristics of the Sower with regard to the concept “from green to gold”. These attributes of the Sower should include the following: Diligence (not being inactive) strategic, good time manager.

Adopt a business continuity plan in case of unexpected issues that may cause a “change” in the original plan and be incremental in ongoing quality control.

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After reading the Daily-Need story, she claimed that these attributes have been used in a variety of ways, as seen in the successful completion of the company’s multi-billion naira factory designed to cGMP NAFDAC standards. , WHO and USFDA which has now positioned the company well for good manufacturing practices.

Professor Adeyeye revealed that Daily-Need was one of the companies that was inspected under the NAFDAC/UNIDO cGMP roadmap using international standards, and some of the indicators in this inspection included three for the site of manufacturing – premises, equipment and utilities.

She enthused: ‘It is good to remember the seed that was sown decades before and how the tender of green led to growth and the golden fruits it yielded’, adding that in the pharmaceutical industry or the regulatory world, there is no unique case.

”The subjugation of the fruits is a continuous effort. Therefore, the Sower must be progressive in continuous quality control. Many of our pharmaceutical companies, including Daily-Need, followed this quality follow-up”.

A company’s proactivity in the aforementioned attributes, she added, will reduce the risk of operational failures. ”For example, the adoption of a business continuity plan due to unforeseen changes. I will give two practical situations; during a pandemic, a business will ensure that customer needs and expectations are met, and the institution continues to operate optimally during these times. Another example is the change in the format for submitting drug registration applications that NAFDAC began implementing about three years ago.”

She commended the leadership of many pharmaceutical companies in Nigeria for seizing the opportunity and increased improvement in submission was witnessed by NAFDAC, pointing out that this is part of change management which is closely linked to the continuous monitoring of the quality.

She further stated that it is also a preparation for when NAFDAC will transition from Maturity Level 3 to ML4 and Global Listed Authority; when our companies can bring their products to market globally through collaborative regulatory registration and trust among national drug regulatory agencies around the world.

The second operational reality, according to Professor Mojisola Adeyeye, the soil on which the seed is planted includes organization, personnel and regulatory space.

“Where the sower plants the seed will determine the results. Daily-Need started with less than thirty (30) employees to over 700 over the past 50 years. Operational realities for this aspect include training to increase the skill level of staff. The second is a solid organizational structure, a necessary strength for any business. The workforce must be well motivated and disciplined.”

Part of the ground, as mentioned, is the regulatory ecosystem. She said that NAFDAC was an integral part of this reality, adding that the culture of good manufacturing practices, which is the foundation on which quality pharmaceutical products are manufactured, has received particular attention from Nigerian pharmaceutical companies through the GMP roadmap which was carried out on 25 companies by NAFDAC/UNIDO and the second roadmap which involved 145 companies.

She said Daily Need was an active participant in the roadmap and proved capable of meeting regulatory expectations.

Professor Mojisola Adeyeye said NAFDAC is committed to supporting innovation and recognizing the pharmaceutical industry through the five-year exclusivity that was introduced to local manufacturers in 2019 for manufacturing and marketing if l company can meet the domestic market demand.

She said creativity in manufacturing can be demonstrated through a focused drive to obtain facility and product pre-qualification, noting that this can also be done with the aim of obtaining WHO certification. or as part of global trade readiness through collaborative registration and trust. among regulators.

”This is highlighted today because of the African Free Trade Agreement (AfcFTA) which allows for free trade between African countries. Nigerian pharmaceutical companies must be prepared to market their products across the continent with quality products that can be approved in the various countries through continental trust among regulators,” she said.

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NAFDAC charges pharmaceutical companies on quality products for the benefit of the AFcFTA

NAFDAC charges pharmaceutical companies on quality products for the benefit of the AFcFTA