Martin Harvey Allchurch

On February 15, 2022, the European Union (EU) announced that Team Europe—the European Commission, the European Medicines Agency (EMA), and EU Member States Belgium, France, and Germany—and the Bill & Melinda Gates Foundation will mobilize more than €100 million over the next five years to support the recently established African Medicines Agency (AMA) and other African medicines regulatory initiatives at regional and national levels.

As part of its contribution to promoting global health, the European Medicines Agency can assess medicines for use outside the European Union (EU) and issue scientific opinions in collaboration with the World Health Organization and non-EU national regulatory authorities. Ten positive scientific opinions have been adopted by the Committee for Medicinal Products for Human Use of the European Medicines Agency medicines (EU-M4all, or article 58). We have investigated for the first time their… Meer weergeven

As part of its contribution to promoting global health, the European Medicines Agency can assess medicines for use outside the European Union (EU) and issue scientific opinions in collaboration with the World Health Organization and non-EU national regulatory authorities. Ten positive scientific opinions have been adopted by the Committee for Medicinal Products for Human Use of the European Medicines Agency medicines (EU-M4all, or article 58). We have investigated for the first time their impact. Minder weergeven

The European Medicines Agency‘s scientific Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on 15 November 2018 for fexinidazole tablets for the treatment of human African trypanosomiasis (HAT; sleeping sickness) caused by the protozoon Trypanosoma brucei gambiense (g-HAT) subspecies. This is a life-threatening neglected tropical disease transmitted by tsetse flies in western and central Africa. T. b. gambiense causes 97% of HAT cases and is responsible for the… Meer weergeven

The European Medicines Agency‘s scientific Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on 15 November 2018 for fexinidazole tablets for the treatment of human African trypanosomiasis (HAT; sleeping sickness) caused by the protozoon Trypanosoma brucei gambiense (g-HAT) subspecies. This is a life-threatening neglected tropical disease transmitted by tsetse flies in western and central Africa. T. b. gambiense causes 97% of HAT cases and is responsible for the chronic form of the disease, which evolves toward a fatal outcome in 2 to 3 years following infection if left untreated. The CHMP opinion on fexinidazole was adopted under a unique evaluation process specifically designed to provide a benefit–risk evaluation for medicines relevant to populations living in regions outside the European Union. The scientific assessment, under Article 58 of Regulation (EC) No 726/2004 was conducted in cooperation with the World Health Organization, in particular with the WHO Department of Control of Neglected Tropical Diseases and involved national competent authorities from the Democratic Republic of the Congo and Uganda, thereby facilitating registration in target countries. Minder weergeven

Authors: Martin Harvey Allchurch, Dirceu Brás Aparecido Barbano, Marie-Hélène Pinheiro, and Janis Lazdin-Helds

ISSN: Online version ISSN 1680-5348

Edited by Sam Halabi, Associate Professor, University of Tulsa College of Law and Scholar, O’Neill Institute for National and Global Health Law, the book brings together analysis and thinking from medicines regulators and academics from around the world.

ISBN 978-0-12-802311-2