Update on Medicines Supply Gaps

Last week Business South Africa reported 41 medicines identified to have availability gaps.

Over the course of the week, 29 of those gaps were addressed.

However, following an update to the demand models against supply, 38 additional gaps were identified. The new gaps are detailed in our latest data request.

We value your ongoing participation in this effort, especially around indicating potential ramp-up capacity (manufacture or import) for identified supply gaps.

SAHPRA is reporting an increased interest in recent weeks around Section 21s from the industry in response to the priority list of medicines released last week.

It has been advised that Section 21 will be considered only as a last-resort after all other registered processes have been explored.

This implies first exploring potential to increase local manufacturing capacity or increasing registered imports.

We are raising this to ensure SAHPRA’s capacity is allocated to the most pressing priorities at this time.

We are working with SAHPRA to put together detailed guidance around Section 21s and other regulatory processes, which we will share in the coming weeks.

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