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2026-08-04

Regulatory Watch

AI-synthesized intelligence from CBN, FIRS, CAC, NAFDAC, SON, and NEPZA — so your business stays ahead of regulatory change.

August 4, 2026 7 updates 2 sources
NAFDAC has intensified its regulatory oversight in the pharmaceutical sector, issuing public alerts on counterfeit drugs, blacklisting a non-compliant manufacturer, and emphasizing proper handling of medical device investigation reports. These actions signal a stricter enforcement environment, urging SMBs in healthcare and related industries to bolster their compliance and quality assurance measures to avoid penalties and protect public health.
What's being regulated
Pharmaceuticals Medical Devices Food and Beverages Export/Import Healthcare
Latest regulatory changes
NAFDAC joins the Federal Ministry of Health and Social Welfare, nutrition partners, and the global community in celebrating World Breastfeeding Week 2026
NAFDAC
NAFDAC celebrates World Breastfeeding Week 2026, promoting breastfeeding as a public health priority.
May lead to increased awareness and potential regulations supporting breastfeeding-friendly practices in food and healthcare sectors.
Handling Manufacturer Investigation Reports for Medical Devices and IVDs
NAFDAC
NAFDAC provides guidance on handling Manufacturer Investigation Reports (MIRs) for medical devices and IVDs to ensure safety and quality.
Medical device and IVD manufacturers must implement robust procedures for reporting and investigating complaints and adverse events to comply with NAFDAC expectations.
Blacklisting of Onifam Laboratories Ltd
NAFDAC
NAFDAC blacklists Onifam Laboratories Ltd and associated entities from pharmaceutical business activities due to regulatory misrepresentation and improper use of approvals.
SMBs in pharma must ensure transparent regulatory compliance; blacklisting can lead to severe business disruption and legal consequences.
Public Alert No. 037/2026 – Alert on Suspected Counterfeit Pulmicort® (Budesonide) Inhalation Suspension
NAFDAC
NAFDAC alerts the public on suspected counterfeit Pulmicort® (Budesonide) in the market, infringing on AstraZeneca's authorization.
Distributors and retailers must verify product authenticity to avoid penalties and protect consumers; increased vigilance in supply chain.
Public Alert No. 036/2026 – Alert on Suspected Counterfeit Products Mimicking Forxiga® (Dapagliflozin)
NAFDAC
NAFDAC alerts on suspected counterfeit Forxiga® (Dapagliflozin) products in Nigeria.
SMBs in pharma distribution must enhance anti-counterfeiting measures and ensure traceability to avoid legal issues.
SON rides on e-platform to facilitate international trade - Business News Nigeria
Other
SON uses an e-platform to facilitate international trade, streamlining processes.
SMBs involved in import/export may benefit from more efficient SON processes, but should stay updated on current digital platforms.
How to Register Your Fish Farm with NEPC Nigeria: A Complete Export Guide - within nigeria
Other
A guide on registering fish farms with NEPC for export purposes.
Fish farm SMBs can explore export opportunities by registering with NEPC, but must comply with NAFDAC and other regulatory requirements.
What this means for your business
Heightened enforcement against counterfeit drugs and non-compliant manufacturers.
Increased focus on medical device safety and quality reporting.
Potential for stricter import/export regulations and digitalization of processes.
Opportunities for SMBs in export markets, especially in agriculture and aquaculture.
Need for robust supply chain integrity and product authentication.
What to do next
1 Review and strengthen internal quality assurance and pharmacovigilance systems.
2 Implement rigorous supplier verification and product authentication protocols.
3 Stay updated on NAFDAC alerts and guidelines, and ensure timely reporting of adverse events.
4 For medical device and IVD companies, develop and implement MIR handling procedures.
5 For fish farms and exporters, register with NEPC and ensure compliance with export standards.
6 Engage with regulatory bodies for clarification and training on new requirements.
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