E-drug: Registration fees (cont)
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The words here below are taken from an unpublished report of a
meeting of experts held in WHO.
"In several countries, the imposition of application, licence, and
annual/retention fees provides a practical way to help meet the
running costs of the drug regulatory authority, of inspections and
other regulation enforcement activities, and to filter out
superfluous and irrelevant applications. If a decision is made in
favor of establishing fees, consideration should be given to the
following points:
a) in line with the market size, fees should be high enough to permit
or at least to contribute significantly to the efficient and
effective functioning of the national drug regulatory system.
b) appropriate mechanisms need to exist within the government
administration to ensure that funds collected as fees are made
available to the drug regulatory authority for use in ensuring that
pharmaceuticals on the market are acceptable in terms of quality,
safety, efficacy, and are rationally used.
c) provisions for fee reduction or exemption should be made in order
to ensure that vital drugs with a limited market are reliably
available.
d) the risk that the collection of fees may induce approval of a
greater number of applications can be contained by appropriate
mechanisms such as transparency of the evaluation process, setting no
relation between fees and evaluation results, and involvement of
institutions external to the drug regulatory authority in
decision-making."
Dr Valerio Reggi
Quality and Safety: Medicines
Department of Essential Drugs and Medicines Policy
World Health Organisation, Geneva
fax: (41) 22 7914730
Valerio Reggi <reggiv@who.ch>
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