News and updates on regulatory affairs.
Kano State has become the first stop in a North-West pharmacovigilance tour aimed at strengthening medicine-safety structures, improving adverse drug reaction reporting and supporting stronger coordination across healthcare facilities.
NAFDAC has approved 450 young pharmacists for its Young Pharmacists Reserve Volunteers Programme after receiving 1,410 applications nationwide. The volunteers will be trained in pharmacovigilance, post-market surveillance and enforcement activities through the Agency's Narcotics and Controlled Substances Directorate, in collaboration with the Young Pharmacists Group and other stakeholders.
NAFDAC has discontinued the registration of oral ketoconazole tablets in Nigeria following severe risks of fatal liver injury, aligning with global regulatory actions
NAFDAC has alerted Nigerians to a suspected counterfeit Pulmicort (budesonide) product marketed as “Ulmicort 0.5 mg/ml Inhalation Suspension”, detected in Eastern Nigeria and currently under investigation.
NAFDAC has alerted Nigerians to two suspected counterfeit products mimicking AstraZeneca’s Forxiga (dapagliflozin), detected in Eastern Nigeria, and directed surveillance and mop-up operations to remove them from circulation.
NAFDAC has warned Nigerians against the marketing and sale of an unregistered product, Menofix Capsules, following complaints and concerns about potential liver-related adverse effects. The agency says the product has not been evaluated for safety, quality, or efficacy.
NAFDAC has joined an international research consortium awarded a £3.7 million UK grant to develop innovative technologies for detecting substandard and falsified vaccines, a move expected to strengthen vaccine quality surveillance and regulatory decision-making in Nigeria.
The Pharmacy Council of Nigeria (PCN) has sealed 383 pharmaceutical premises across 11 Local Government Areas of Ogun State following a four-day enforcement exercise aimed at strengthening regulatory compliance and protecting public health.
The Pharmacy Council of Nigeria (PCN) has disclosed that some of its regulatory provisions are currently under review, with proposed reforms expected to make aspects of enforcement more balanced while maintaining professional standards. The disclosure came in response to concerns raised by community pharmacists during the ACPN Town Hall Meeting at the association's 45th Annual International Scientific Conference.
The Director-General of the National Agency for Food and Drug Administration and Control (NAFDAC), Prof. Mojisola Adeyeye, has clarified that while the agency evaluates the quality and safety of herbal medicines before registration, manufacturers—not the regulator—are responsible for generating clinical evidence to demonstrate that their products are effective.
NAFDAC has defended its ongoing enforcement of Nigeria's ban on sachet alcohol and alcoholic beverages in containers smaller than 200 ml, warning that manufacturers who continue to violate the regulations risk severe sanctions. The agency says the policy is aimed at protecting children and reducing alcohol-related harm.
NAFDAC says the enforcement of Nigeria's ban on sachet alcohol was not abrupt, noting that manufacturers were granted a six-year transition period following a 2018 agreement involving industry groups and the Federal Ministry of Health.
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