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

WHO Expert Committee on Specifications for Pharmaceutical Preparations Forty-seventh report
7.3 Screening technologies
The Expert Committee was briefed on new developments regarding analytical
screening technologies. It was reported that some falsified medicines would
produce wrong results, as they may have been deliberately prepared to produce
false-positive results. In addition, WHO increasingly receives requests from
countries for assistance in dealing with cases of suspect medicines causing serious
health problems to patients.
The Expert Committee expressed concern at this growing issue.
Members discussed possible causes and solutions, although they recognized that
the most effective analytical and forensic solutions were likely to be expensive.
In particular, it was stressed that WHO could not effectively find a solution
without collaboration with stakeholders, such as manufacturers and regulatory
authorities. The secretariat was requested to review the trends of new laboratory
technologies and to report back to the Expert Committee.
7.4 Survey on laboratories report
A survey was initiated among WHO collaborating centres and those participating
in the EQAAS, being mainly national quality control laboratories (QCLs), to
determine the number of QCLs that were involved in testing suspect samples
and how they deal with such samples. The data are still being analysed but will be
provided to the Expert Committee when they become available.
The Expert Committee welcomed this initiative and noted the report.
WHO Technical Report Series, No. 981, 2013
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