Proceedings of the Tenth International Conference of Drug Regulatory Authorities (ICDRA) - Hong Kong, China, 24 - 27 June 2002
(2002; 166 pages) View the PDF document
Table of Contents
View the documentAbbreviations and acronyms used in this report
Open this folder and view contentsOpening ceremony
Open this folder and view contentsHerbal medicines
Open this folder and view contentsKeynote address
Open this folder and view contentsSafety of blood-derived products
Open this folder and view contentsAntimicrobial resistance - new initiatives
Open this folder and view contentsHarmonization I
Open this folder and view contentsHarmonization II
Open this folder and view contentsProtection of trial subjects in clinical trials
Open this folder and view contentsRegulating biotechnology products
Open this folder and view contentsRegulatory challenges: health sector reform and drug regulatory capacity
Close this folderAccess to drugs and vaccines I
View the documentGeneric medicines: old problems and new challenges from a European perspective
View the documentAccess to quality pharmaceuticals: the Indian experience
View the documentQuality of starting materials for drugs and vaccines
View the documentFixed-combination medicines: an Australian perspective
View the documentDrugs for neglected diseases: challenges for regulators
View the documentRecommendations
Open this folder and view contentsAccess to drugs and vaccines II
Open this folder and view contentsCounterfeit pharmaceutical products
Open this folder and view contentsHomoeopathy
Open this folder and view contentsSafety monitoring
Open this folder and view contentsE-Commerce
Open this folder and view contentsCurrent topics
Open this folder and view contentsRegulatory challenges of new technologies
View the documentList of participants
View the documentBack cover
 

Drugs for neglected diseases: challenges for regulators

Dr Krisantha Weerasuriya, WHO, South-East Asia Region

Neglected diseases are generally tropical diseases, for which there is a lack of effective drugs. There is often a high disease burden in particular areas and sometimes a fatal outcome. The most neglected diseases include visceral leishmaniasis, African trypanosomiasis and Chagas disease.

In the past 25 years, 1393 new chemical entities have been granted market authorization. Among these, there were only 16 drugs for neglected diseases, all of which were included in the WHO Model List of Essential Drugs. Of the other 1377, only 21 were considered important enough to be included in the WHO List.

At present, there are no significant projects to develop drugs for the neglected diseases initiated by the pharmaceutical industry. A few products are in the pipeline but the industry is involved as partners with non-industry institutions; this situation is unlikely to change in the future. Therefore, a major challenge for regulators is to play a role in encouraging the development of these drugs. This is most pertinent for regulators in the developing world, who might consider fast-track registration, limited-release schemes for specific products, and joint evaluation of new products of public health importance.

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