VaccRelease 2.0
Regulatory and scientific capacity development in the field of official lot release of vaccines and other biologicals
Context
Many African countries are striving to establish local vaccine production. However, a strong regulatory system is a prerequisite for the long-term success of this endeavour. This includes competencies to independently test and release locally produced vaccines. The project aims to provide safe and effective vaccines and biomedical medicines in Africa. VaccRelease 2.0, therefore, continues to provide targeted support to African project countries and networks in establishing effective structures and processes for the independent lot release. The project supports the development and implementation of independent lot testing in the control laboratories in Rwanda and Ghana is further promoted through regulatory and scientific training. It further provides guidance for troubleshooting efforts and hands-on work relating to the implementation process in local contexts. VaccRelease 2.0 also strengthens the Regional Centres of Regulatory Excellence for lot testing in South Africa and Egypt, which provide training to other regulators in Africa. By doing so, the project enables knowledge transfer in Africa and promotes South-South cooperation. In addition, VaccRelease 2.0 supports the Network of African Reliance Laboratories and the African Medicines Quality Forum to establish harmonised regulatory guidelines for lot testing across Africa. The project complements the activities of other national and international organisations working in this field.
Objective
Improved availability of vaccines and other biological products in African countries by strengthening the capacity of members of the African Reliance Laboratories Network to perform official lot release
In Cooperation with
- Food and Drugs Authority Ghana, Accra, Ghana
- Rwanda Food and Drugs Authority, Kigali, Rwanda
- South African National Control Laboratory for Biological Products, Bloemfontein, South Africa
- Egyptian Drug Authority, Egypt, Cairo, Egypt
- African Union Development Agency – New Partnership for Africa’s Development (AUDA NEPAD) und African Medicines Quality Forum (AMQF), Johannesburg, South Africa
Thematic priorities
Facts
Activities
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Networking and cooperation
The project supports the collaboration with national regulatory authorities and national control labs based in sub-Saharan Africa and with the African Medicines Agency (AMA), AMQF, and regional organisations. Thereby, VaccRelease 2.0 fosters a reliance system specifically for locally produced vaccines.
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Capacity building
VaccRelease 2.0 supports national regulatory authorities and national control labs in establishing the official lot release function for vaccines by developing and promoting the implementation of lot release standards and processes and by establishing the governance structures for vaccine lot release. Support is also provided for developing an information system and standardised procedures for handling complaints, quality issues and recalls of vaccine lots.
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Training and competence development
VaccRelease 2.0 promotes capacity building at the individual level through needs-based practical training and support in developing regulatory documents for lot release.
