Last Updated

07 Nov 2019

EDCTP Call For Proposals: Ethics and regulatory capacities 2019

The purpose of this call for proposals is to fund projects that are designed to support sub-Saharan African countries to establish and/or develop robust national medicines regulatory systems and capacities for ethical review of clinical research and use of medicinal products and technologies in humans, as well as national and international collaboration in compliance with established, internationally acceptable good practices. This scheme targets projects with the active involvement of NECs and/or NRAs from countries with both weak and strong ethics and regulatory capacities in sub-Saharan Africa.

The objectives of this call are to:

  1. Improve the efficiency of the functioning of NECs and NRAs through the introduction of innovative systems, reliance practices and/or technologies that would facilitate the various functions of these bodies with better quality outputs and improved timelines;
  2. Promote quality control systems and process for NECs and NRAs, certification and accreditation of the various bodies, as well as adherence to international standards;
  3. Promote international cooperation in ethics and regulatory activities through the transfer of promising and successful innovative systems and/or technologies from other regions outside Africa and within Africa, fostering national and regional collaboration among these bodies;
  4. Strengthen linkages between ethics and regulatory functions with other important structures, such as clinical trial registries and systematic reviewers whilst simultaneously enforcing the sharing of data in compliance with global requirements;
  5. Promote the adoption and update of AVAREF, WHO, and other international standards and best practices by countries, groups of countries, or regional harmonisation initiatives;
  6. Support already established training centers to provide both innovative training and mentorship to NECs and NRAs.

Proposals should include support for development or scale-up of innovative systems and technologies that support ethics and regulatory functions, training, networking and promotion of good practices and evidence-based adoption of accreditation models from relevant internationally endorsed/peer-reviewed documented sources.

Closing date is November 21, 2019. 


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