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[e-drug] Unified licensure/regulation (con'd)

E-drug: Unified licensure/regulation (con'd)

The role of WHO / PAHO is to guide governments who are
responsible for quality of medical products released on their national
markets, and manufacturers, in so far as production of quality of
pharmaceuticals and biologicals is concerned. Already, there are
fairly uniformly agreed standards followed for the production and
quality assurance of essential drugs and also bilogicals/vaccines. You
will need to check the appropriate WHO / PAHO websites for this
info. These standards give guidance for the setting up of product
licensing scheme and also informs the structure of regulatory
instruments in each country. Bear in mind that each country has its
peculiarities to contend with, and therefore a uniform structure would
be questionable. However, a release of guidance notes with
emphasis on 'what needs to be in the licensing and regulatory
instruments' would not go amiss.

The core problem is that many countries do not have adequate
resources to operate effective licensing and regulatory institutions.
However, the lack of such infrastructure does not and should not
even imply that governments should accept products whose quality
does not meet internationally accepted standards for quality, safety
and effectiveness. Of course, a government has sole liability for the
health of its people, with respect to what products it releases onto its
market for use by its people, and therefore it (government) can take
whatever decision it deems fit. This is the reason why in principle, a
government cannot afford to 'cut corners' with quality, and
enforcement of applicable regulations. Where a country does not
have an effective regulatory infrastructure, the problem of quality
assurance can be tackled in more than one way: A government can
contract independent inspectorates (eg, iinstitutions of the
internationally recognised convention of pharmaceutical inspectors) to
inspect a manufacturer's processes, management, etc. A government
can also contract independent and internationally recognised quality
assurance laboratories to test the quality of raw materials and
finished products supplied by the manufacturer, before goods are
procured. WHO and other UN agencies working in health are
available to work with governments in this area.


Bonnie Fundafunda
Contracts Officer
UNICEF - Supply Division (Immunisation)
e-mail: bfundafunda@unicef.org
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