Page 178 - SAMRC Annual Report 2024-2025

The primary objectives of this programme are: • Increasing the capacity and efficiency of regulation
of clinical trials and health product registration
• Improving research infrastructure at public and use in South Africa;
universities and recognized research institutions
to enable internationally competitive/world class • Ensuring optimal use and availability of research,
vaccine research and development throughout development, testing and production infrastructure
the value chain to be conducted in South Africa; in the country and encouraging collaboration; and
• Establishing and/or improving and/or expanding • Attracting, developing and retaining high-
GMP-accredited pilot production facilities for the end scientific and technological skills and
smaller scale production of mRNA and non-mRNA- competencies.
based vaccines, for example for clinical testing; The main anticipated outputs of the programme are
• Establishing and/or improving and/or expanding as follows:
training facilities for vaccine research, development
and manufacture to build human resource capacity;

OUTPUTS
1 2 3 4

Procurement and Procurement and Procurement Procurement and
installation of installation of vaccine and installation installation of
equipment at a technology laboratory of laboratory equipment supporting
pilot plant for active training equipment equipment and the digitalization as
pharmaceutical potentially attached support infrastructure well as the regulation
ingredients (API) using to a pilot plant or for upgrading and capacities of SAHPRA
mRNA technology equivalent facility modernizing research
facilities including
Procurement and animal facilities and
installation of laboratories
equipment at a pilot
plant for API with
other than mRNA
technology

Project implementation officially commenced on Products Regulatory Authority (SAHPRA) aimed at
1 April 2024. For Outputs 1 – 3, a national open RFA leveraging technology to efficiently and effectively
process was launched, inviting proposals from role- execute their regulatory duties in the vaccine
players involved in vaccine research, development, R&D, manufacturing and registration/approval
pre-clinical testing and pilot-scale production in processes. Digitalization of SAHPRA’s identified
South Africa requiring equipment and infrastructure business processes will enable SAHPRA to achieve
support to strengthen their capacity to contribute to its strategic objective of becoming a WHO ML4
the country’s vaccine innovation and manufacturing country and WHO Listed Authority.
ecosystem. Following a rigorous international peer
review process, the DSTI with approval from KfW, The SAMRC, as the DSTI’s Project Executing Agency,
awarded equipment and infrastructure support to is commencing with procurement of the awarded
18 organisations comprising of universities, science equipment and infrastructure on behalf of the
councils and private entities. programme beneficiaries in compliance with the
South African and German public sector procurement
For Output 4, a closed RFA and Project Steering frameworks. This will result in substantial bolstering
Committee review process was followed, of the vaccine development, testing and pilot scale
resulting in an award to the South African Health manufacturing capability in the country.

176 SAMRC ANNUAL REPOR T 2024-25