ASAQ... Quality
Quality Formulation
The novel ASAQ “bilayer” tablet provides a separation of the two compounds as studies showed that, when mixed together, AS and AQ are not sufficiently stable. One of DNDi’s FACT partners, Ellipse Pharma, initially developed this innovation as well as a process of manufacturing which allowed them to reduce the size and number of tablets to be administered and to obtain stable products with a 2-year shelf-life in tropical climates when packaged appropriately. Licensed from DNDi in December 2004, these innovations are now utilized by sanofi-aventis in large-scale production.
Quality Manufacturing
Made in the South for use in the South, ASAQ is produced in Morocco, in line with sanofi-aventis’ commitment to maintain its industrial assets in “Southern” countries, with the same quality standards worldwide. Product quality assurance, guaranteeing the high quality and purity of the active ingredients, is ensured throughout the supply and production chain. The ASAQ manufacturing site in Morocco complies with international manufacturing standards and with the worldwide sanofi-aventis quality standards.
Quality Development
The regulatory approval process aims at ensuring that ASAQ is made available to patients as soon as possible, while, at the same time, demonstrating adherence to international quality standards. In order to expedite access of this quality product to the patients who need it most and in compliance with international regulatory standards, sanofi-aventis has submitted a full registration dossier in Morocco, where the non-fixed combination is already registered. Marketing approval was granted by Moroccan authorities on February 1, 2007. As further evidence that ASAQ meets international quality standards, sanofi-aventis submitted a dossier to the WHO pre-qualification process in February 2007.
Quality Implementation
Providing drugs is not enough. To ensure equitable access to and proper use throughout all levels of the health care system, DNDi and sanofi-aventis will engage a number of partners, including individual experts, countries and regions, WHO and international organisations, funding agencies, and NGOs.
Information and education initiatives, aimed at healthcare personnel and malaria patients, will accompany implementation, if requested by countries, to encourage proper malaria management (including the appropriate use of ACTs), and to increase awareness of malaria prevention.
Enabling pharmacovigilance of the deployed ACT and ensuring drug efficacy and quality are also vital. In addition to efforts by national programs and international programs like the WHO, DNDi will bring support to sanofi-aventis and other partners such as Epicentre/MSF to conduct follow-up studies of efficacy and safety in the field so that high-quality clinical data on ASAQ is collected through sentinel sites in Africa.
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