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

WHO Expert Committee on Specifications for Pharmaceutical Preparations Forty-seventh report
Guidelines on submission of documentation for a multisource
(generic) finished pharmaceutical product
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Develop a new general document for the quality part based on
the specific guidance developed for the WHO Prequalification of
Medicines Programme.
Develop a new general document for the variations based on the
specific guidance developed for the WHO Prequalification of
Medicines Programme.
Provision by health-care professionals of patient-specific preparations for
children that are not available as authorized products: points to consider
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Further develop these “points to consider” jointly with FIP as
a practice guidance document for compounding, focusing on
paediatrics.
Update on biowaiver and comparator products
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Provide an update of the list of possible biowaivers and comparator
products following review by the members of the Expert Committee
to replace the version of 2002.
Sampling procedures for monitoring of market situations
WHO Technical Report Series, No. 981, 2013
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Continue development of sampling procedures based on the
numerous examples obtained from many countries as feedback to
the secretariat's communications.
Screening technologies procedures for monitoring of market situations
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Review the trends in new technologies for screening suspect
samples.
Quality assurance terminology
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Continue the work on the preferred terms included in the current
quality assurance terminology database based on the analysis
prepared by the secretariat, with a group of experts, for which a
consultation had already started.