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October 2012                   

By Nathalie Strub-Wourgaft,
DNDi Medical Director

The need for regulatory harmonization (i.e. either allowing for centralized drug registration in multiple countries as one single approval, or mutual recognition which entails expediting registration in additional countries once a drug has been registered in a primary country with sufficient regulatory  capacities) in order to reduce the duplication of research efforts, use resources more efficiently, and especially to speed up the process to reach patients, was identified decades ago in Europe. The process took nearly 40 years to come to fruition (EMEA created in 1995 and EEC in 1957). This context is important to bear in mind when we analyse regulatory harmonization processes in neglected-disease endemic countries.


21-24 October 2012
World Health Summit (Berlin, Germany)

DNDi is hosting a session entitled "Overcoming Regulatory Barriers to Meet Priority Health Needs in Developing Countries - Putting Theory into Practice", and will give presentations in other sessions.

WHO pre-qualifies fixed-dose combination of Artesunate and Mefloquine (ASMQ FDC) produced by DNDi’s Indian industrial partner Cipla
On 12 September 2012, WHO granted pre-qualification of ASMQ FDC, produced by Cipla, which will facilitate its registration throughout Asia. The combination of AS and MQ is one of five Artemisinin Combination Therapies (ACTs) currently recommended by WHO for the treatment of uncomplicated P. falciparum malaria, and is the first-line treatment in a number of South East Asian countries. ASMQ FDC was registered in India in 2011 and in Malaysia in early 2012. In India, about 18,000 adult patients have already been treated with this combinaton.
SSG&PM adopted as first-line treatment in Kenya's national visceral leishmaniasis (VL) guidelines
Kenya's Ministry of Health released on 26 September 2012, its national guidelines for diagnostic techniques and improved treatment regimens for patients suffering from VL, with SSG&PM as first-line treatment. Dr Davis Wachira from the Ministry of Public and Health and Sanitation of Kenya, explains the importance for Kenya to diagnose and treat VL patients.
Listen to Podcast
Brazilian Ministry of Health, FIOCRUZ, and DNDi to Fight Neglected Diseases through R&D Partnership
The three actors signed a strategic partnership to collaborate on research and development (R&D) for new therapies and diagnostics for neglected diseases. The strategy aims to boost innovation in the field of neglected diseases and provide new health tools to Brazil’s public health programmes.

First patients recruited in implementation study for new visceral leishmaniasis (VL)  treatments in Asia
DNDi, together with its partners, is implementing a four-year project including 10'000 patients in clinical and pharmacovigilance studies for diagnosis and treatment of VL in India and Bangladesh. The project will support control and elimination strategies in both countries, where the concentration of disease burden is among the world's highest.

Voices for Neglected Diseases
It’s early on the morning of Thursday, 23 August 2012. We are at the Chemolingot Sub-district Hospital, where SSG&PM treatment is being administered to patients suffering from kala-azar (visceral leishmaniasis). In one of the wards, sitting on a hospital bed, is Lemarus Tebakwani Lukeno, a 23-year-old kala-azar patient, who has been undergoing treatment for five days.
Read more about Lemarus' story.
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