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. 2021 Aug 27;8:742200. doi: 10.3389/fmed.2021.742200

Table 4.

Extent of scientific assessment for full review.

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
a

For biosimilar products not approved by a reference agency only.