Prequalification of Active Pharmaceutical Ingredients -
By submitting an
application for prequalification the applicant understands
and agrees to the conditions of the active pharmaceutical
ingredient (API) prequalification
procedure, as outlined in the
WHO Technical Report Series
TRS953, Annex 4.
A summary of the key conditions is outlined below.
Inclusion in the list of prequalified
APIs does not constitute
a WHO endorsement or warranty of fitness of the API for a
particular purpose, including its use in a particular
finished pharmaceutical product (FPP) and the safety or efficacy of that
FPP in the treatment of specific
remains the ultimate responsibility of the manufacturer of
the FPP to ensure that the API, as accepted in principle, is
suitable for the manufacture of the specific pharmaceutical
The decision to list an API is based
upon information available to WHO at the time of
This decision is subject to change should
new information become available to WHO.
If serious safety or quality concerns arise in
relation to a prequalified API, WHO may delist the API
or suspend the API until results of further investigation
become available and are evaluated by WHO.
Applicants are required to communicate to WHO any changes in manufacture and control that may have
an impact on the safety, efficacy and quality of their
It is the applicant's responsibility to provide
WHO with the appropriate documentation to prove that any
intended or implemented change will not have an impact on
the quality of the API that has been prequalified.
WHO reserves the right to terminate
evaluation of a specific application if the applicant
is unable to provide the required information, or is
unable to implement any corrective actions that WHO may
require within a specified time period, or if the
information supplied is not adequate for completion of the
As WHO is responsible for the quality
assessment of the API, ownership of all related assessment reports lies
Thus, WHO shall be entitled to use and publish such
reports, subject always to the protection of any
commercially-sensitive, confidential information of the
manufacturer. Notwithstanding the foregoing, WHO reserves the right to
share full evaluation reports and inspection reports with
the relevant authorities of any interested Member State of
WHO or any other United Nations agency.