E-DRUG: Prequalification factsheet by WHO
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[At the WHO Assembly last week the USA delegation tried hard to suppress
WHO's prequalification project from the resolutions. To inform countries
better what the WHO Prequalification is, WHO published the attached
factsheet. WB]
Key Facts about the WHO Prequalification Project
The Prequalification project, set up in 2001, is a service provided by the
World Health Organization (WHO) to facilitate access to medicines that meet
unified standards of quality, safety and efficacy for HIV/AIDS, malaria and
tuberculosis.
From the outset, the project was supported by UNAIDS, UNICEF, UNFPA and the
World Bank as a concrete contribution to the United Nations priority goal of
addressing widespread diseases in countries with limited access to quality
medicines.
How it works
Prequalification was originally intended to give United Nations procurement
agencies, such as UNICEF the choice of a range of quality medicines. With
time, the growing list of products (i.e. medicines) that have been found to
meet the set requirements has come to be seen as a useful tool for anyone
bulk purchasing medicines, including countries themselves and other
organizations. For instance, the Global Fund to Fight AIDS, Tuberculosis and
Malaria disburses money for medicines that have been prequalified by the WHO
process.
Any manufacturer wishing their medicines to be included in the prequalified
products list is invited to apply. Each manufacturer must present extensive
information on the product (or products) submitted to allow qualified
assessment teams to evaluate its quality, safety and efficacy. The
manufacturer must also open its manufacturing sites to an inspection team
which assesses working procedures for compliance with WHO Good Manufacturing
Practices (GMP). Alternatively, the inspections carried out by stringent
regulatory bodies are recognized and their work is not duplicated by WHO.
The standards against which the assessment teams evaluate both the quality
specifications of medicines and the manufacturing sites are based on the
principles and practices agreed by the world�s leading regulatory agencies
and adopted by the WHO Expert Committee on Specification for Pharmaceutical
Preparations. In other words:
The manufacturer provides a comprehensive set of data about the quality,
safety and efficacy of its product, including details about the purity of
all ingredients used in manufacture, data about finished products, such as
information about stability, and the results of in vivo bioequivalence tests
(clinical trials conducted in healthy volunteers).
The team of assessors evaluates all the data presented and if satisfied with
the evidence sends the product to professional control testing laboratories
contracted by WHO in France, South Africa or Switzerland for analytical
verification of quality.
If the product is found to meet the specified requirements, and the
manufacturing site complies with GMP, both the product linked to this
manufacturing site and company are added to a list hosted by WHO on a public
web site.
The list of medicines
All product and manufacturing site requirements, standards used in
evaluating the product and the profile of the inspection teams are outlined
on the following web site: http://mednet3.who.int/prequal/. The site also
includes the list of prequalified medicines and their manufacturers.
The assessment teams evaluating the products and manufacturers include
experts from some of the national regulatory authorities of the European
Union as well as Canada and Switzerland. These teams ensure that high
quality, international standards are respected. The teams work with
regulators from the developing countries where the medicines will be used to
make sure that the process and results are at all times transparent and
trusted by the end-users.
The prequalification process takes a minimum of three months if the product
meets all the required standards. When products do not meet the appropriate
standards the process can be longer and if the manufacturer fails to prove
the quality, safety and efficacy of its medicine it will not be
prequalified. Inclusion in the list does not mean that the prequalified
status of a product lasts forever. All medicines are requalified after three
years, or earlier, if needed. WHO also carries out random quality control
testing of prequalified medicines that have been supplied to countries.
Medicines which have been found to meet the required standards so far are
from both brand name (42 medicines) and generic (61 medicines)
manufacturers. These include 62 antiretrovirals and 33 medicines for
HIV/AIDS related diseases; two antimalarials and six drugs for the treatment
of tuberculosis.
Both medicines containing one active ingredient and those combining several
active ingredients in one pill, usually called fixed-dose combination drugs,
have been prequalified. For tuberculosis, there is one quadruple
(four-in-one pill) and one double (two-in-one) fixed dose combination drug
and for malaria one double fixed dose combination drug has been approved.
In the case of AIDS medicines, two different triple (three-in-one)
fixed-dose combination drugs have recently been approved; one from an
originator company and the other from two different generic companies.
The principles for assessing the quality of fixed-dose combination drugs are
the same as those used by the European Agency for the Evaluation of
Medicinal Products (EMEA) and the USA Food and Drug Administration (FDA). In
other words, the prequalification assessment team evaluates the required
data, including in vivo bioequivalence tests carried out by the
manufacturers. The fixed-dose combination drug is tested against the
separate medicines taken together in the same dosage as is present in the
fixed-dose combination pill.
In soliciting applications from companies, WHO does not question whether the
products presented are patented or generic, since patent laws vary according
to different national legal systems. It suffices that a company is duly
authorized for pharmaceutical manufacture in its own country and that the
final product meets stringent standards of quality, efficacy and safety.
An integrated process
The availability of quality, safety and efficacy of medicines is a major
concern of WHO. To ensure that quality pharmaceuticals are available, WHO
sets norms and standards, develops guidelines and advises Member States on
issues related to quality assurance of medicines in national and
international markets. WHO assists countries in building national regulatory
capacity through networking, training and information sharing. These
activities have been endorsed and supported by Member States through
numerous World Health Assembly resolutions.
The Prequalification project is part of these activities and mandate. It
does not intend to replace national regulatory authorities or national
authorization systems for importation of medicines. Prequalification draws
from the expertise of some of the best national regulatory authorities to
provide a list of prequalified products that comply with unified
international standards.
This is why, both in 2002 and in 2004, the International Conference of Drug
Regulatory Authorities (ICDRA), made up of more than 100 national medicines
regulatory authorities, made a formal recommendation that "WHO should
continue the Pre-qualification Project of medicines for priority disease
programmes, particularly for HIV/AIDS, malaria and tuberculosis".
- For more information on WHO Prequalification project, please visit the
website- http://mednet3.who.int/prequal/
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