Initiative to collaborate in assessment and inspections for medicines registrations with objectives to:
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Reduce workload
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Develop Regulatory Strategy
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Training Platform
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Reduce registration timelines
Reduce workload
Countries work on common applications (dossiers) which are submitted for registration. A manufacturer who submitted an application to at least two of the participating countries can request to have their products assessed jointly (via Zazibona)
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Confidence in regulatory collaboration
For the same applications, GMP inspections are then carried out on the manufacturing sites where the products which are considered for joint assessment are manufactured
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Training Platform
The objectives of the training programmes are:
To provide academic, technical and managerial training to regulators
Skills enhancement through hands-on training, twinning and exchange programmes
Implementation of national / regional programmes in support of medicine and other health products regulation and harmonisation
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Reduce registration timelines
Countries work on common applications (dossiers) which are submitted for registration. A manufacturer who submitted an application to at least two of the participating countries can request to have their products assessed jointly (via Zazibona)
Read More
Read More