The commissioning of Sam Pharmaceutical Ltd today is a testament to the power of collaboration and innovation in Nigeria’s pharmaceutical industry.
The Director General of NAFDAC, Professor Mojisola Adeyeye, gracing this occasion as the woman of the day as all speaker at the event applaud her efforts in encouraging local manufacturing in Nigeria.
Professor Adeyeye’s leadership has been instrumental in shaping the pharmaceutical industry’s growth, particularly with the introduction of the 5-by-5 policy.
This bold initiative has encouraged local manufacturers to strive for excellence, resulting in a significant increase in local production, now standing at 50% compared to the previous 30%.
The impact of her policies is evident in the strides made by companies like Sam Pharmaceuticals.
The DG’s unwavering commitment to quality and safety has earned NAFDAC the prestigious ML3 regulatory status, a testament to her hard work.
As we celebrate not just the opening of a new facility, but a milestone in Nigeria’s pharmaceutical journey, with more local manufacturing outfits emerging, we’re seeing a shift towards self-sufficiency, making essential medicines more accessible and affordable.
Professor Adeyeye, was commended for her tireless efforts in driving this change.
Her legacy will continue to inspire and shape the future of Nigeria’s healthcare sector.
NAFDAC’s 5+5 policy drives foreign investment, and strengthens local pharmaceutical production.
In enforcing the policy, the following steps are to be strictly followed:
At the point of first product registration, companies will be given a statement that foreign manufacturers will be required to either form partnerships with Nigerian companies or/and set up a local manufacturing plants for FPPs, APIs, non-APIs, packaging materials, etc.
A product registration license is valid for 5 years and by the end of the 4th year of license validity, companies are required to submit draft blueprints of proposed partnerships with Nigerian companies or/and set up local manufacturing plant.
Renewal in Year Five: Upon successful renewal for another 5 years for companies with verifiable blueprints, NAFDAC will monitor the migration of the imported drugs to local production.
At the end of Year 7 (First 5 years + 2 years into renewal), if there is no progress on migration to local manufacturing as detailed in the blueprint, an alert for de-registration will be sent to the company at the beginning of year 9.
For Products that have already enjoyed more than two cycles of renewals, companies are required to submit immediate BLUEPRINT on migration to local manufacturing.
Where a manufacturer has more than one product, a verifiable blueprint for local production of at least one product will be acceptable and allowed.
Another achievement which has also impacted on pharmaceutical industries is the Global Benchmarking.
The WHO Benchmarking Programme (ISO 9004) commenced in January 2018 and since then the Agency has imbibed a culture of self – audit as part of WHO-Global Benchmarking requirements and in line with International Best Practices.
She has continued to improve NAFDAC’s maturity level since the first WHO Audit in June 2019.
NAFDAC under Prof Adeyeye had worked assiduously towards attaining Maturity Level 3 to enable Nigeria to strengthen systems and enable Nigeria to manufacture vaccines.
This is also based on continuous self-audit in all regulatory processes that could improve the image of the Agency and Nigeria.
WHO re-benchmarked the Agency between February 21and 25, 2022.
The result positioned Nigeria in ML3.
The ML3 rating means NAFDAC had been found to attain a stable, well-functioning, integrated regulatory system under the leadership of Prof Mojisola Adeyeye.
NAFDAC is now positioned among the list of global NRAs transitioning into the WHO Listed Authorities (WLA)– that is globally recognized as an NRA meeting WHO and other international standards.
It would interest you to know that only four (4) Africa NRAs: Nigeria, Tanzania, Ghana, and Egypt have been ranked ML3 as effective regulatory systems on the continent.
As a matter of fact, fewer than 30% of the world’s regulatory authorities are considered fully functioning and operational.