E-DRUG: Relying on Stringent Drug Regulatory Authorities?
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Dear E-druggers,
Suriname is a small country (population 0.5 million) in South America
with limited capacity in the public pharmaceutical sector and there are
many countries in a similar position. For some years the discussion is
regularly flaring up with regards to the policy to allow medicines on
the Suriname market.
The debate is about the sensibility and practicality to rely on
medicines that are on the market in countries with stringent Drug
Regulatory Authority instead of maintaining a Suriname DRA, of which we
know that it lacks the capacity needed to study and validate
applications with related drug files.
Countries with stringent DRA include member countries of the
Pharmaceutical Inspection Convention Scheme (PIC/S) or of the
International Conference on Harmonization (ICH). In recent years the
number of countries being member have increased considerably.
PIC/S-countries are Argentina, Australia, Austria, Belgium, Canada,
Czech Republic, Cyprus, Denmark, Estonia, Finland, France, Germany,
Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein,
Malaysia, Malta, Netherlands, Norway, Poland, Portugal, Romania,
Singapore, Slovak Republic, South Africa, Spain, Sweden, Switzerland,
United Kingdom. ICH-countries are European Union member states, Japan,
United States of America.
To a certain extent, the Global Fund applies the policy of allowing the
use of medicines approved by stringent DRAs as well as medicines
pre-qualified under the WHO Prequalification project. The key question
seems to be if being a member of PIC/S or ICH does guarantee to an
acceptable level the good quality of the medicines that are allowed on
the markets in those countries and whether it is a reliable reference for
countries like Suriname to rely on. Will this be a better policy than the
current practice of relying on the (weak) capacity of local DRA to make
their own judgments based on medicines files?
I would like to hear your opinion and experience.
Regards
Rob Verhage, pharmacist
HERA Pharmaceutical Consultant
Tawajakoerastraat 4
PO Box 4002
Paramaribo
Suriname
+597 438966 or +597 8561109
verhager@cq-link.sr
Pascal Verhoeven
Pharmacist/independent consultant
Netherlands
verhoeven.pascal@gmail.com