WHO Technical Report Series, No. 981 - World Health Organization

2. General policy
2.1 Cross-cutting pharmaceutical quality assurance issues
The Secretary to the Expert Committee gave a short overview of the general
principles and working procedures of this Committee. She reminded the members
of the Expert Committee that this was one of WHO’s oldest Expert Committees
and that its work and its reports had long been seen as very significant for the
Organization. She presented the report of the forty-sixth meeting of the Expert
Committee of October 2011, which had been published during the year. She noted
recent activities of the Expert Committees on Biological Standardization and on
the Selection and Use of Essential Medicines, and mentioned recent publications
on herbal and complementary medicines.
WHO Technical Report Series, No. 981, 2013
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2.2 International collaboration
2.2.1 Collaboration with international organizations and agencies
The Global Fund to Fight AIDS, Tuberculosis and Malaria
The work of the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM)
was summarized for members of the Expert Committee. GFATM has so far
funded antiretroviral (ARV) treatment for 3.6 million people, treatment for 9.3
million people newly diagnosed with infectious tuberculosis, 260 million malaria
medicine treatments and has distributed 270 million insecticide-treated bednets.
It was noted that there was a continuing need to balance the international
standards of GFATM with the standards and requirements of individual countries.
Procurement is done according to model quality assurance system (MQAS)
principles and according to national and international laws. The Global Fund
has a strict selection process, defined in its quality assurance policy, so quality
standards must be assured either by WHO/PQP or by a stringent regulatory
authority. When no products meet these standards, products reviewed by an
Expert Review Panel (ERP) can be considered, but only under strict conditions.
Countries are requested to monitor quality throughout the supply chain.
The Global Fund's ERP (hosted by EMP/QSM) reviews the dossiers of
products. So far the ERP has performed a risk–benefit assessment of 58 dossiers
on ARVs, of which 29 (50%) were successful; 291 dossiers on antituberculosis
medicines, of which 96 (33%) were successful, and 68 dossiers on antimalarials,
of which 22 (32%) were successful.
QSM's support to the Global Fund is provided through the prequalification
programmes for medicines and quality control laboratories (QCLs), QSM
technical expertise, the monographs (on ARVs, artemisinin combination therapy
(ACT), antituberculosis and anti-infective medicines) of The International
Pharmacopoeia, and through the development and updating of quality assurance
guidelines.