By Adeleye Kunle
Prof Mojisola Adeyeye, Director-General of the National Agency for Food Administration and Control, NAFDAC, has encouraged Nigerian pharmaceutical companies to be ready to trade high-quality products across the continent that can be approved in different countries thanks to continental cooperation among regulators.
Adeyeye, who stated that the African Free Trade Agreement, AfcFTA, allows free trade among African countries, emphasized the importance of research and development (R&D) as a creative and innovative process that many companies will need to incorporate into the manufacturing environment.
Speaking at the 50th Anniversary of Daily-Need Industries Limited in Lagos on “From Green to Gold: Operational Realities in the Twenty-First Century,” she stated that this will encourage research and clinical trials of new molecules, immune-modulators, and complementary alternative medicines, particularly for some noncommunicable diseases such as cancer and diabetes.
Adeyeye added that the COVID-19 pandemic has taught Nigeria to embrace as long overdue the manufacturing of vaccines, active pharmaceutical ingredients, and excipients, emphasizing that Nigeria will remain insecure until we have at least five companies manufacturing pharmaceutical ingredients and one or two companies manufacturing vaccines.
She expressed confidence that the diligence, strategic leadership, and response to challenges through improvement in the manufacturing premise with continuous quality monitoring will generate a future where innovation and creativity will be embraced for drug security, health security, and, ultimately, universal health coverage.
“Daily-Need started with one product, Penicillin Ointment, and has grown to over 20 product categories.” According to Ecclesiastes 11:6, “sow your seed in the morning, and let your hands not be idle in the evening, for you do not know which will succeed, whether this or that, or whether both will do equally well.”
Adeyeye stated that this sheds light on operational realities in any century, particularly the twenty-first, as she identified the three operational realities in pharmaceutical development as The Sower, The Soil, and Creativity and Innovation of the Sower.
Adeyeye stated that Daily-Need was one of the companies that were inspected using international standards under the NAFDAC/UNIDO cGMP Road Map, and some of the indicators for that inspection included three for the manufacturing site – premise, equipment, and utilities.
She praised the leadership of many pharmaceutical companies in Nigeria for rising to the occasion, and NAFDAC noted increased improvement in the submission, emphasizing that this is part of change management, which is inextricably linked to continuous quality monitoring.
She also stated that it is a preparation for when NAFDAC will progress from Maturity Level 3 to Maturity Level 4 and World Listed Authority; when our companies will be able to trade their products globally through regulatory collaborative registration and reliance among national medicine regulatory agencies worldwide.
Adeyeye stated that NAFDAC is committed to fostering innovation and recognizing the pharmaceutical industry through the Five-year Exclusivity Program, which was introduced to local manufacturers in 2019 for manufacturing and marketing if the company can meet in-country market demand.
She stated that manufacturing creativity can be demonstrated through a targeted drive to achieve pre-qualification of the facility and product, noting that this can also be done to obtain WHO certification or as part of the preparation for global trade through collaborative registration and reliance among regulators.
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