81296106-Training and Organizational Development support to the South African Health Products Regulatory Authority to attain WHO Maturity Level 4

The Covid-19 pandemic magnified the critical need for Africa to be able to increase its ability to respond to pandemics and other health crises. The COVID-19 pandemic had a devastating effect on South Africa. It is against this background that the German Federal Ministry for Economic Cooperation and Development (BMZ), committed its support to South Africa through the project, Vaccines for Africa: Vaccine Roll Out and Production in South Africa (SAVax). The project SAVax is commissioned by BMZ and implemented by Deutsche Gesellschaft für Internationale Zusammenarbeit (GIZ) GmbH between January 2022 and December 2025.

SAVax"s objective is to improve access to vaccines for all population groups in South Africa. In order to achieve this objective, the project works along two components, (a) supporting the COVID-19 vaccine roll-out and; (b) strengthening the main stakeholders for vaccine production in South Africa. This tender will focus on the second component (b), the strengthening of local vaccine production in South Africa.

A key stakeholder in vaccine production is the national regulatory authority that ensures the quality and safety of vaccines produced. SAVax is working to provide technical support to South Africa"s regulatory authority, i.e., South African Health Products Regulatory Authority (SAHPRA). The goals of the technical support will be to strengthen the capacity of SAHPRA to regulate the vaccine and pharmaceutical sector in South Africa using efficient digital work processes.

SAHPRA has set itself a goal to reach World Health Organization (WHO) Maturity Level (ML) 4 by 2025. The categorization of WHO ML 4 gives the assessment that a country"s regulatory system is operating at an advanced level of performance and continuous improvement. Through the technical support provided by SAVax to SAHPRA, the goal of the tender will be to support SAHPRA to attain WHO ML 4 status by 2025.

It is within this context that informs the needs for this Terms of Reference (ToR), to find a suitable contractor to support the objectives as described of SAVax"s collaboration with SAHPRA.