BioVoice News December 2016-January 2017 Issue 8 Volume 1 - Page 32

expert corner

Need for a stringent National Regulatory Authority for procurement of anti-Tuberculosis medicines

This article by veteran expert John F . Loeber , examines the requirement of strict or stringent National Regulatory Authority ( NRA ) environments for procurement of anti-tuberculosis ( TB ) medicines , with specific focus on the World Health Organisation , United Nations Office for Project Services , Stop TB Partnership / Global Drug Facility and The Global Fund to Fight Aids , Tuberculosis and Malaria .

The Global Drug Facility ( GDF ) operates as the procurement arm of the Stop TB Partnership ( TBP ) Secretariat , hosted at the World Health Organization ( WHO ), Geneva , Switzerland , from 2001 until 2014 and forthwith at the United Nations Office for Project Services ( UNOPS ). The Stop TB Partnership is a network of some 1,300 governments , donors , industry , NGOs , academia and other partners , joined in the

common fight against tuberculosis ( TB ). The TBP i . a . provides access for countries to quality assured , affordable anti- TB medicines via GDF . As of 2014 GDF has delivered medicines for 24 mn TB patients to 133 countries in thirteen years of operation , financed by bilateral and multilateral donors such as USAID , The Global Fund and UNITAID . GDF ’ s annual purchases of TB medicines amounted to about 200 mn US $ in 2013 , and the Global Fund disbursed approximately 500 mn US $ for TB in 2015 .
1 . STRINGENT NRA REQUIREMENT
A condition for procurement of anti-TB medicines by the GDF or facilitation of direct procurement by countries has been and continues to be that medicines are approved under the WHO Prequalification Programme or licensed for marketing by stringent National Regulatory Authorities ( NRAs ). This is established in the
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BioVoiceNews | December 2016 - January 2017