Table 4.
Mozambique | Namibia | South Africa | Tanzania | Zambia | Zimbabwe | |
---|---|---|---|---|---|---|
Chemistry, manufacturing and control (CMC) data extensive assessment | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
Non-clinical data extensive assessment | ✘ | ✘ | ✓ | ✓ | ✓ | ✓a |
Clinical data extensive assessment | ✘ | ✘ | ✓ | ✓ | ✓ | ✓a |
Bioequivalence data extensive assessment | ✘ | ✓ | ✓ | ✓ | ✓ | ✓ |
Additional information obtained (where appropriate) | ||||||
Other agencies internal review reports | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
Medical and scientific literature | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
For biosimilar products not approved by a reference agency only.