Exploring Medicines Regulatory Harmonisation

Consultation on Regulatory Harmonisation in the SADC Region

Supporting Medicines Harmonisation in the SADC Region

Significant steps have been taken to increase regional harmonisation in the assessment of pharmaceutical products. The European Medicines Agency is one such example. In recent years, regional harmonisation in Africa has also become a greater focus of attention, with the East African Community taking active measures to increase regional regulatory harmonisation of medicinal products.
Recognising the progress made, with the support of WHO and NEPAD, in the EAC region and with respect to generic medicines, the World Bank is exploring similar initiatives in the SADC and ECOWAS regions. The World Bank initiatives has a particular focus on harmonisation of vaccine review and approval processes. The overall objective is to facilitate timely registration of new vaccines in these countries so that they may be made available earlier to vulnerable populations.
TESS supported a consultation process for countries of the SADC region, including:

  • identify and engage key regional stakeholders
  • implement a survey of Heads of Regulatory Agency
  • support a consultation meeting to feedback on findings

This work will contribute to the initiative led by the SADC Secretariat, in support of the ZaZiBoNa and other activities, to further the process of medicines regulatory harmonisation within the SADC Region.

Project Details



Support to the World Bank

SADC Region