South African Development Community (SADC)

v. 28 – Q4 2023

Member countries: Angola, Botswana, Comoros, Democratic Republic of Congo, Eswatini, Lesotho, Madagascar, Malawi, Mauritius, Mozambique, Namibia, Seychelles, South Africa, Tanzania, Zambia, and Zimbabwe

Minor Update: Separate development in Zambia.

Market Executive Summary The Southern African Development Community (SADC) is developing regional harmonized medicines guidelines. The SADC published guidelines for product barcoding (QR codes). The 16 member countries are currently reviewing the guidelines and expect Serialisation and Traceability requirement to follow.

The AMA (African Medicines Agency) was developed in November 2021 to ensure a healthy African population with access to quality, safe, and efficacious medical products and technologies. Although not fully in place with a clear direction, 15 countries have signed up to the AMA Treaty. The AMA is the second continental health agency aimed to enhance the capacity of State Parties and Regional Economic Communities in order to regulate medical products.

Note: Separate development in Zambia which has announced separate national requirements that appear not to be co-ordinated with any SADC initiative, see Market Sheet Zambia (new in V27).

Key Dates None

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