Professor Adeyeye and her team during the briefing
By Chinyere Amaechi
National Agency for Food and Drug Administration Control, NAFDAC, the nation’s regulatory authority, has stepped up on its mandate in safeguarding public health in the country through a robust science based regulatory framework which mandates bioavailability and bioequivalence, BE, for all medicinal products that qualify for such studies in Nigeria otherwise referred to as generic products.
This is handed out to health reporters in Lagos by the NAFDAC Director General, DG, Professor Mojisola Adeyeye at a press conference on Thursday.
The briefing is the outcome of NAFDAC stakeholders weeklong workshop on good clinical practice which was on its fourth day as at the time of the press briefing
Prior to the workshop the DG disclosed, NAFDAC had issued comprehensive regulations and guidelines to the pharmaceutical industry detailing stakeholders on how to achieve therapeutically equivalent generic drug products through BE studies.
Additionally, she said that a specific notice has been released to the industry targeting contract research organisations to also key into the initiative.
Professor Adeyeye also told journalists that, for optimal impact, NAFDAC is investing heavily on capacity building by training its critical staffers and stakeholders including healthcare practitioners, researchers, contract research organisations and industry players on the initiative to ensure a shared understanding for smooth, effective, and sustainable implementation.
Furthermore, Professor Adeyeye who said; to achieve the initiative, NAFDAC has developed strategic roadmap which it is implementing systematically to align stakeholders and facilitate compliance, added that the press briefing is one of the series of engagements designed to keep stakeholders informed and involved as NAFDAC is committed to uphold and to ensure quality, safety and efficacy of generic medicines in Nigeria, by mandating the BE studies. The agency therefore calls on all stakeholders and the general public to support the initiative as well as prioritise the use of generic products that have undergone rigorous regulatory examinations and duly approved by NAFDAC.
Bioequivalence is a critical scientific concept that doubly ensures the quality, safety and efficacy of generic drug products when compared with their innovator counterparts. It establishes the interchangeability of generic medicines with their innovator equivalent. It is a term used in pharmacology and regulatory concerns to describe the similarity in bioavailability between two or more formations of a drug. On the other hand, Bioavailability is the rate and extent to which the active ingredient of a drug is absorbed into the blood stream and becomes available at the site of action.
Though some nations have embraced the initiative for the upward of 10 and above years, Nigeria began to demand for the efficacy of the generic ingredients of its products five years ago. This is because, the basic requirements for take-off like the technicalities, skill, infrastructure or ennobling environment were not available until recently. According to the NAFDAC DG, this is our best time to join, moreso, Nigeria is one of the very few nations that have embraced the initiative in Africa.
She is also optimistic that though the nation is just embracing this science of confirmation, NAFDAC has been diligent ensuring that the products that are approved for consumption are products that have been evaluated in other countries.
Generic drug products are expected to imbibe similar clinical outcome when used like their innovator counterparts
BE is an ecosystem that NAFDAC as a regulator is building to ensure that generic products, GPs, are safe and efficacious, hence being GP should not diminish their efficacy but instead increase public confidence in such medicines.
It is going to be executed in phases while prioritizing essential drug products like; anti-malaria drugs, antibiotics, maternal and pediatric products.
Generic drugs are medications that are equivalent to brand-name drugs in terms of their active ingredients, dosage, strength and intended use. Implementing Bio studies fosters confidence in the therapeutic equivalence of generic medicines which are widely used in Nigeria.
BE establishes the interchangeability of generic medicines with their innovator equivalent relying on their statistically significant clinical outcome to confirm that generics drugs deliver comparable therapeutic effects.
Innovator drugs undergo vigorous stages of clinical trials and scientific evaluations. Generic drug products are expected to imbibe similar clinical outcome when used in healthcare settings or our homes. To confirm that they are therapeutically equivalent and interchangeable or capable of managing conditions as effectively as their innovators, Bio availability and bioequivalent studies are done on them.
The initiative promotes public health by reducing the circulation of substandard or falsified medicines thereby averting therapeutic failures and boosting trust in the pharmaceutical and healthcare industries
