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2026-08-05

Regulatory Watch

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

August 5, 2026 7 updates 2 sources
NAFDAC has intensified enforcement against counterfeit pharmaceuticals and regulatory non-compliance, including blacklisting a manufacturer and issuing public alerts on fake drugs. Concurrently, NAFDAC is promoting public health initiatives like breastfeeding and providing guidance on medical device investigations. These actions signal a stricter regulatory environment for pharmaceutical and medical device businesses, emphasizing the need for robust compliance and vigilance against counterfeit products.
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 is participating in World Breastfeeding Week 2026 (August 1-7) to promote breastfeeding awareness and support.
May lead to increased scrutiny of breast milk substitutes and marketing practices; SMBs in baby food and formula sectors should ensure compliance with marketing regulations.
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 assess complaints and adverse events.
Medical device and IVD manufacturers and importers must establish robust procedures for MIR handling to ensure timely reporting and compliance.
Blacklisting of Onifam Laboratories Ltd
NAFDAC
NAFDAC blacklisted Onifam Laboratories Ltd and associated entities from pharmaceutical business activities due to regulatory misrepresentation and improper use of approvals.
SMBs in pharmaceutical distribution must verify the legitimacy of their supply chain partners to avoid association with blacklisted entities and ensure compliance.
Public Alert No. 037/2026 – Alert on Suspected Counterfeit Pulmicort® (Budesonide) Inhalation Suspension
NAFDAC
NAFDAC alerts the public on suspected counterfeit Pulmicort® (Budesonide) inhalation suspension in the Nigerian market.
Pharmacies and distributors must check product authenticity and report suspected counterfeits; SMBs in pharmaceutical distribution should enhance anti-counterfeiting measures.
Public Alert No. 036/2026 – Alert on Suspected Counterfeit Products Mimicking Forxiga® (Dapagliflozin)
NAFDAC
NAFDAC alerts the public on suspected counterfeit Forxiga® (dapagliflozin) products in the Nigerian market.
Similar to the Pulmicort alert, this requires vigilance in the supply chain to prevent counterfeit products from reaching consumers.
SON rides on e-platform to facilitate international trade - Business News Nigeria
Other
SON is using an electronic platform to facilitate international trade, likely streamlining certification and import/export processes.
SMBs involved in import/export should leverage SON's e-platform for faster processing and ensure compliance with standards.
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, highlighting the process and benefits.
Fish farming SMBs looking to export should follow NEPC registration to access export incentives and international markets.
What this means for your business
Increased enforcement against counterfeit pharmaceuticals and regulatory violations.
Need for enhanced supply chain due diligence to avoid blacklisted entities.
Growing emphasis on public health initiatives may affect marketing of certain products.
Digitalization of regulatory processes (SON e-platform) offers efficiency gains.
Export opportunities in agriculture (fish farming) require proper registration with NEPC.
What to do next
1 Review and strengthen internal procedures for handling adverse events and MIRs for medical devices.
2 Conduct due diligence on all suppliers and partners to ensure they are not blacklisted by NAFDAC.
3 Implement anti-counterfeiting measures such as product verification and secure packaging.
4 Stay updated on NAFDAC public alerts and withdraw any affected products immediately.
5 For exporters, register with relevant agencies (NEPC, SON) and utilize e-platforms for trade facilitation.
6 Ensure marketing practices for baby food and formula comply with breastfeeding promotion regulations.
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