Library / regulatory-reference
Zambia: Zambia Medicines Regulatory Authority (ZAMRA)
Audience: administrators-policy, researchers-scientists ยท Review state: published
The national authority
The Zambia Medicines Regulatory Authority, known as ZAMRA, is Zambia's national regulator for medicines and allied substances, established under national medicines law and operating under the Ministry of Health.
Zambia's market is import-dominated, and the authority's registration, licensing and port-inspection work controls what enters the country.
How products enter the market
Medicines require registration after evaluation of quality, safety and efficacy, and manufacturers, importers, wholesalers and pharmacies are licensed. Imported consignments can be sampled and tested before release.
Post-market work includes pharmacovigilance reporting, market surveillance and recalls, supported by laboratory quality-control testing.
Regional and international role
The authority is an active participant in the Southern African regional joint-assessment initiative known as ZAZIBONA, where regulators share evaluation work to shorten registration timelines across participating countries.
That reliance model makes the authority's assessments consequential beyond Zambia's borders and a reference case for work-sharing among African regulators.
Using this profile
The authority publishes guidelines, registers and safety communications in English through its official portal, which is the primary source for current rules and listed in this profile's internal reference record.
For cross-country comparison: ZAMRA illustrates the work-sharing regulator: a national authority whose participation in regional joint assessment multiplies its regulatory reach.
Limitations
Educational profile of a national regulatory system, current as of drafting. It simplifies routes and classes and is not legal, regulatory, or clinical advice. Filing and compliance decisions must be confirmed against the authority's current published rules and, where needed, professional regulatory counsel.