NAFDAC sets new standards for drug safety in Nigeria
The National Agency for Food and Drug Administration and Control has reaffirmed its commitment to ensuring the quality, safety, and efficacy of generic medicines in Nigeria by enforcing stringent bioequivalence studies.
Speaking on Thursday in Lagos, the Director General, NAFDAC, Prof Moji Adeyeye, said the initiative, aimed at boosting public confidence in generic drugs, seeks to prevent the circulation of substandard medications and ensure that generics provide comparable therapeutic effects to their branded counterparts.
Bioequivalence studies are vital scientific assessments that confirm the interchangeability of generic medicines with their innovator counterparts.
These studies guarantee that generic drugs deliver similar clinical outcomes, ensuring their effectiveness in managing health conditions.
She said, “By mandating bioequivalence studies, NAFDAC is strengthening its regulatory framework to safeguard public health.
“This measure not only enhances trust in the pharmaceutical industry but also encourages rational prescribing practices.”
Adeyeye said to align stakeholders and facilitate compliance, NAFDAC had outlined a strategic roadmap that included issuing comprehensive regulations and guidelines to the pharmaceutical industry.
The agency has also released a “Note to Industry” detailing requirements for Contract Research Organisations, both of which are available on NAFDAC’s official website.
Additionally, she noted that NAFDAC was investing in capacity building by training its staff and key industry players, including healthcare practitioners, researchers, and CROs.
“These training sessions ensure a shared understanding and smooth implementation of bioequivalence studies in Nigeria.
“The regulatory agency has reiterated its commitment to upholding stringent scientific standards, urging all stakeholders to support the initiative.
“We call on pharmaceutical companies and healthcare providers to prioritise the use of generics that have undergone rigorous regulatory scrutiny and are duly approved by NAFDAC,” said Adeyeye.
She maintained that the press briefing was part of a broader series of engagements designed to keep stakeholders informed and involved in the agency’s efforts to maintain a robust pharmaceutical regulatory system in Nigeria.
