Registering New Drugs: The African Context

New Tools for New Times

[19 February, 2010]

This report was launched in Pretoria, at the COHRED (Council on Health Research for Development) & NEPAD (New Partnership for Africa’s Development) meeting on pharmaceutical innovation in Africa, on February 19, 2010. More info.

  • What would be the best registration strategy for the approval of a new drug to treat sleeping sickness, a disease which primarily affects neglected patients in Central and West Africa?
  • What would be the best way to support African regulatory authorities in their evaluation of new drugs specifically developed to treat their own populations?
  • How should essential standards for the conduct of clinical trials be defined?

These are some of the issues addressed in the new report sponsored by DNDi and commissioned to the Health Policy Division of the George Institute for International Health on the challenges of registering new drugs for neglected diseases in the African context.

Download the report: “Registering New Drugs: The African context”



Press release:
Read the press release: “New recommendations to enhance registration processes of drugs for neglected diseases in Africa / A report commissioned by DNDi assesses pathways to facilitate review of new neglected diseases’ drugs by African experts”


Read more about:

  • DNDi‘s Regulatory workshop, Nairobi, Kenya [June 24, 2009]
  • PLoS Medicine: “Registering New Drugs for Low-Income Countries: The African Challenge” [February 2011, Vol 8]
  • The Lancet: “Building medical regulatory authorities in Africa” [April 2010, Vol 10]


Although this research project originates from DNDi’s own registration issues and needs, the issues addressed in the report are of relevance to most Product Development Partnerships (PDP) working in the field of Neglected Diseases. There is a need to think about new mechanisms and pathways, based on international cooperation, to ensure the urgent approval in developing countries of new drugs and treatments, which are safe, effective and of quality.

The report offers a review of the benefits and limitations of the various regulatory pathways available today to support such registration.

It concludes with several recommendations based on increased collaboration between regulatory authorities of developing countries, developed countries and the WHO, with the objectives of:

  1. managing scarce regulatory resources in the short term to fill the capacity gap, and
  2. strengthening African regulatory agencies in the medium to long-term.