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

WHO Expert Committee on Specifications for Pharmaceutical Preparations Forty-seventh report
of international comparator pharmaceutical products for the equivalence testing
and assessment of interchangeable multisource (generic) products and included
a decision-tree for use in identifying comparator pharmaceutical products.
The list was intended to serve as an information tool for medicines regulatory
authorities and manufacturers of pharmaceuticals, although it was not intended
to be binding on those responsible for choosing a reference product. At that time
the Expert Committee noted that the list and the guidance provided would need
to be updated periodically.
A revision of the comparator list is in progress. The aim is to have a list of
suitable comparators of acceptable quality that is harmonized with the PQP list
and which contains products that are easily accessible.
The Expert Committee expressed its thanks for the continuing work on
comparator products,
WHO Technical Report Series, No. 981, 2013
12.6 Biowaiver
The term “biowaiver” is applied to a regulatory medicines approval process
when the dossier is approved on the basis of evidence of equivalence other than
through in vivo equivalence testing. A series of monographs have been published
that contain essentially literature reviews, gathering and organizing relevant data
that should be taken into consideration in deciding whether a biowaiver could
be recommended for a new formulation of a specific API. Further work on these
biowaiver reviews has been done by FIP. Some 40–50 reviews of APIs have been
published. These scientific reviews provide the basis upon which to update the
related annex (WHO Technical Report Series, No. 937, 2006, Annex 8), published
together with the Multisource (generic) pharmaceuticals: guidelines on registration
requirements to establish interchangeability (WHO Technical Report Series,
No. 937, 2006, Annex 7).
The Expert Committee noted the situation and thanked FIP for its
work in this area. The Committee encouraged continuing efforts to update this
annex in collaboration with the WHO collaborating centre, to circulate the
draft for comments and to present the draft revision to the next meeting of the
Expert Committee.
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