Beschreibung der Beschaffung
The project "Vaccines for Africa: Roll-out and Production in South Africa" (SAVax) is commissioned by the German Ministry for Economic Cooperation and Development (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.
For SAVax to achieve this objective, the project works along two components: (a) Support to the COVID-19 vaccine roll-out in South Africa and (b) Strengthening of the main stakeholders for local production of vaccines in South Africa. The services to be provided focus on component (b) to strengthen local vaccine production in South Africa.
The backbone of being able to produce local vaccines is to have an efficient national regulatory authority to ensure the quality and safety of the vaccines produced. SAVax is providing technical support to South Africa"s regulatory authority, the South African Health Products Regulatory Authority (SAHPRA), to strengthen the capacity of SAHPRA to regulate the vaccine and pharmaceutical sector in South Africa.
The South African National Control Laboratory for Biological Products (SANCL) conducts vaccine release testing. SANCL services SAHPRA exclusively to perform Human vaccine Lot Release before product is released into the market.
The technical support provided by SAVax to SAHPRA has been bracketed into four activities: (a) training interventions for key regulatory processes, (b) organizational development, (c) digitalization of central work-processes of the organization, and (d) support for the coordination of development partner support. The services requested of the contractor for this tender will focus on activities (a) and (b).
The contractor will be responsible for delivering the following work packages to fulfil the technical support. The work packages as described below will be segmented into milestones with defined outputs and delivery dates.
- Work Package 1 - Training Interventions: The contractor will conduct training interventions (assessments, curriculum, training implementation) for SAHPRA and the SANCL. The training required is for SAHPRA and SANCL staff, on various regulatory topics relevant for SAHPRA to reach WHO ML 4 status. Following five regulatory topics for training interventions have been identified through a series of workshops with SAHPRA are:
a) Good Manufacturing Practice (GMP) Inspection of biological medicines and vaccines manufacturers,
b) Clinical Trials Evaluation,
c) Biological and Biosimilar medicines and Vaccine dossier evaluation process,
d) Clinical and Bioequivalence Evaluation
e) Vaccines lot release.
- Work Package 2 - Organizational Development: The contractor is expected to provide services in support of SAHPRA"s organizational development in context of achieving WHO ML4 and the anticipated evolution and requirements of the regulatory and pharmaceutical landscape in the mid to long term of South Africa and broader continental needs. The service to be provided entails (a) assessment of the future regulatory environment of SAHPRA, (b) support to SAHPRA in shaping and defining an organizational culture, (c) development of a change management strategy/plan as well as (d) providing training interventions for the development of relevant change management skills for SAHPRA staff.
Experts for Work Package 1 and Work Package 2:
The contractor will be required to provide the below listed experts to fulfil the training goals of Work Package 1. The experts listed will provide training in the designated regulatory topics to SAHPRA and SANCL staff. The contractor will also be required to provide and pool of 3 experts (an expert pool) to fulfil the goals of Work Package 2
(1) Team-lead for the overall coherence and co-ordination of the work packages and training.
(2) Trainer for GMP Inspections of biological medicines and vaccines manufacturers
(3) Trainer for Clinical Trials Evaluation
(4) Trainer for Biological and Biosimilar medicines and Vaccine dossier evaluation process
(5) Trainer for Clinical and Bioequivalence Evaluation
(6) Trainer for Vaccine Lot Release
(7) Assessor of future regulatory environment relevant for SAHPRA
(8) An expert pool for Organizational Development of SAHPRA.
A description of the experience and qualifications of each expert is detailed in the accompanying Terms of Reference (ToR). Project timelines, milestones and format of the tender are also detailed in the ToR, including further context and description of services to be provided by the contractor.