Home / Regulatory
Regulatory
Approvals, registrations, inspections, licensing, policy and medical devices.
Latest in Regulatory
Zambia’s ZAMRA and NHRA sign agreement on clinical trial oversight
Zambia’s Medicines Regulatory Authority (ZAMRA) and National Health Research Authority (NHRA) have signed a memorandum of understanding on the authorisation […]
BoMRA lists device categories exempt from import clearance in Botswana
Botswana’s medicines regulator has told importers, clearing agents and port of entry authorities that nine categories of medical devices and […]
SAHPRA retains WHO Maturity Level 3 for vaccine regulation
South Africa’s Health Products Regulatory Authority (SAHPRA) has retained WHO Maturity Level 3 (ML3) for the regulation of vaccines as […]
Botswana opens draft regulations under new Medicines Act for comment
Botswana’s medicines regulator has opened draft regulations under the Medicines and Related Substances Act 2025 for stakeholder comment, setting the […]
Kenya names 13 manufacturers building pharmaceutical plants
The Pharmacy and Poisons Board says the projects, ranging from a penicillin plant to vaccine and KEMRI facilities, support a target of producing half of essential health...
Maharashtra FDA Cancels Cipla Pune Distribution Unit’s Drug Licence Over Reactin Plus Violations
MUMBAI, India — The Maharashtra Food and Drug Administration (FDA) has cancelled the drug sale licences of a Carrying and Forwarding […]
Mozambique’s ANARME reaches WHO Maturity Level 3 for medicines
The authority becomes the tenth in Africa and the first in a Portuguese-speaking African country to reach ML3, covering medicines and imported vaccines.
Ethiopia benchmarks medical device regulation ahead of WHO assessment
EFDA assessed its system for devices and in vitro diagnostics against more than 250 WHO indicators, setting a roadmap towards formal benchmarking after reaching Maturity Level 3...
Kenya’s PPB plans national track and trace system for health products
The regulator has also issued the country's first Good Pharmacy Practice standards and says it is supporting 13 new manufacturers, as it sets out its record at...
NDLEA destroys 330 tonnes of seized narcotics in Lagos
The agency put the value of the consignment at 301.1 billion naira and carried out the destruction under a Federal High Court order, with opioids among the...
Get alerts
Independent pharmaceutical news and regulatory intelligence covering Africa.
Regulatory alerts and news, direct to your inbox
Independent pharmaceutical news and regulatory intelligence covering Africa.