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 To Member
Countries
To WHO
The need
for making available quality diagnostic kits for screening, diagnosis and
surveillance of diseases was recognized, especially in developing countries where
infections such as HIV/AIDS, hepatitis B and hepatitis C have emerged as
diseases of great public health significance. Realizing that currently many
shortcomings exist in the regulatory mechanism for diagnostic kits, the
participants made the following recommendations
To Member Countries
 The Member Countries should adapt generic
policy guidelines for assuring the quality of diagnostic reagents/devices in
consonance with their local laws governing the quality of other drugs and
devices to support diagnostic services and thereby facilitate quality of
care. The guidelines will be implemented through National Drug/Devices
Control Authority in whom all the legal powers will be vested.
As far as possible, an independent laboratory
should be recognized as the National Reference Laboratory for diagnostic
kits. If this is not feasible, more than one laboratory may be designated as
National Reference Laboratory for a specific category of diagnostic kits.
These laboratories must have quality management system, meet international
standards, get themselves accredited to an international agency and provide
technical support to the National Regulatory Authority in all matters
pertaining to diagnostic kits.
The Member Countries should constitute
Advisory Committees for National Regulatory Authority (NRA) and the National
Reference Laboratories (NRL) that will undertake evaluation of diagnostic
kits.
NRA, on the advice of the national committee,
should develop guidelines based on international criteria for manufacturers/importers
to get the quality of diagnostic kits assessed for certification, licensing
and registration.
The
Member Countries should provide adequate infrastructure, human resources and
financial inputs to ensure that an efficient national regulatory mechanism
becomes operational and is sustained.
The
National Reference Laboratory should also act as the National Focal Point for
the Member Country for all international technical issues.
The
training of professional staff employed in the National Regulatory Authority
and Laboratory may be arranged in those countries where the regulatory
mechanisms are fully functional. Assistance from WHO may be sought for
capacity-building as well as for the procurement of international standards
and reference materials.
Member
Countries will initiate National External Quality Assessment Schemes in
HIV/AIDS, hepatitis B and hepatitis C. The results of these NEQAS shall be
made available to the National Reference Laboratories to monitor their
competence and also to indicate the performance of various kits that have
been used.
To
WHO
WHO
should continue advocacy at the highest level in Member Countries for
assuring the quality of diagnostic kits.
WHO
should facilitate capacity-building, training of personnel from regulatory
agencies and procurement of international standards and reference materials
to support development of efficient infrastructure in Member Countries.
WHO
should coordinate the development of an electronic network between various
regulatory agencies to facilitate rapid exchange of information, data and
technical advances.
WHO
should organize an intercountry workshop for
laboratories undertaking evaluation of diagnostic kits to harmonize the
specifications for quality assessment of diagnostic kits and to avoid intercountry variations in certification and licensing of
these diagnostic kits.
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