The collaboration established between the Indian and Canadian NRAs and WHO facilitated the registration in India as well as the prequalification by WHO.
In addition to regulatory capacity building, institutions such as UNIDO, WHO (Prequalification Project), and DfID support specific local pharmaceutical producers of, primarily, antiretrovirals, anti-TB and antimalarials in achieving WHO prequalification [ 31– 31].
Initiatives such as the WHO Prequalification Programme (WHO Prequal) [ 16] and the tentative approval system of the United States (US) Food and Drug Administration FDAA) [ 17, 18] not only ensure that ARVs procured with donor funds meet international quality standards, but also influence the rate and extent of ARV dispersion across low- and middle-income countries.
The lack of guidance and the absence of an internationally recognized system for evaluation of generic products, such as the WHO prequalification system set for vaccines, HIV, TB and Malaria medicines, are major obstacles impairing the search for alternative quality-assured options to the innovator product.
This study was conducted to support the efficacy and tolerability of the sulfadoxine/pyrimethamine FDC tablet in the World Health Organization's (WHO) Prequalification of Medicines Programme, as well as to obtain marketing authorization in China.
Among these girls was sixteen-year-old Ri Sol Ju, the daughter of a top officer in North Korea's Air Force, who, four or five years later, would go on to marry Kim Jong Un. (A commentator told Newsweek that Ri's work as a cheerleader served as a sort of prequalification for marrying the dictator).
Joe Mollica, an owner of Connecticut Financial Mortgage, a mortgage broker in Stamford, Conn., says that some listing agents won't even consider potential bidders who are not recently preapproved, and generally won't accept the quicker prequalification letter as a substitute either.
This result indicates that BRBs experience significantly different demands in a system than those imposed by simple axial test as required by the BRB prequalification test.
This long-term assessment will need to include the use of PsA-TT in infants as part of EPI, following prequalification of the PsA-TT pediatric indication by WHO.
The contractor prequalification problem is used as an example.
