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Regulatory

Meeting Report: The Road to Regulatory Harmonization for Africa
The Road to Regulatory Harmonization for Africa:
Accelerating Access to Essential Medicines and Vaccines

DNDi Meeting Report
Nairobi, Kenya, 4 June 2013

In June 2013, on the occasion of its 10th anniversary, DNDi and founding partner KEMRI brought together key African decision makers and public health actors to explore the challenges for research and development in Africa at a 2-day meeting entitled “A Decade of R&D for Neglected Diseases in Africa”. The first day focused on regulatory harmonization with a view to accelerating access to essential medicines and vaccines in Africa. Representatives from 20 African countries together with 15 others from Europe, Asia and the United States, including over 360 African regulators, ministers of health, WHO representatives and public health experts, investigators, national control programme representatives, clinical trial and data managers, research and training institutes, and others were present. This resulting document examines the progress made to date, in anticipation of further discussions.

Download the report [PDF | 1.16MB]


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Registering New Drugs: The African context
New tools for new times


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 [PDF | 3.7MB]: "Registering New Drugs: The African context"

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:

Read the articles of:
  • 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.


Read DNDi's Regulatory policy



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