E-DRUG: Relying on Stringent Drug Regulatory Authorities? (5)
-------------------------------------------------------------
Thanks Patrick, Bonface and Raffaella!
We have been unclear in the original message where we used wording like
'instead of maintaining a Suriname DRA...'
1) sorry, we didn't mean to abolish the Surinamese DRA; we agree with
the comments made that the in-country activities like product
registration (at the minimum as a basic dossier validation), quality
control and pharmaco-vigilance, licensing of pharmacies, importers, and
wholesalers still needs to be operationalized in-country by the
competent authority and be backed up by adequate legislation and
political support. Especially in view of post-marketing assurances.
Obviously strengthened as much as possible where it is found to be weak
e.g. dossier evaluation, inspectorate, analytical laboratory functions.
Small DRA's in countries with little voice to complain may benefit from
the work done for same products in stronger developed countries.
Nevertheless in our original posting, we would like to hear about other
views where E-druggers think that assuming that 'pre-market quality'
from the Netherlands, Greece, Malaysia or South-Africa (just to name a
few) on the basis of '...actually being on the market in country of
origin', is too naive. Or maybe too easy. We also like to specify
'actually on the market' more in detail. For instance a UKMHRA approval
could be provided by a supplier for a product manufactured in India with
barely a significant number of batches being actually used in the UK, or
couldn't it?. Then there are dossiers for a EU country and formulas used
for other markets. Or the approval sometimes relates to one of multiple
production blocks or a production line only and there may be conditional
compliance's to be fulfilled...
2) Maybe we could make the list of stringent regulated countries more
concrete by summarizing as follows:
Argentina, Australia, Austria, Belgium, Canada, Cyprus, Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland,
Italy, Japan, Latvia, Liechtenstein, Lithuania, Luxembourg, Malaysia,
Malta, Netherlands, Norway, Poland, Portugal, Romania, Singapore,
Slovakia, Slovenia, Spain, Sweden, Switzerland, South Africa, United
Kingdom, United States of America.
In italic: seen as adopting ICH principles (CTD dossier) but not (yet)
member of PIC/s (GMP recognition); underlined: PIC/s member but not
necessarily (yet) adopting CTD dossier format.
Feedback welcome. We would think that some others could be at PIC/s
level but cannot substantiate that.
Where in between would you place Brazil, Cuba, Mexico, Puerto Rico,
Morocco, China, India, Pakistan, Iran, Russia, Jordan, Oman, Sri Lanka,
Bangladesh and Indonesia as (contract manufacturing) exporters of
generic medicines or even vaccines?
3) A formal exchange of data between regulators in the above countries
and a small DRA is indeed a very good point to make because essential
drugs do circle around a relative limited list of sources in not too
many countries (per region or otherwise). The overlap of the actual
products/sources between the stringent countries and a small DRA in a
developing country may nevertheless be too small to collaborate on
product or factory level. In fact the current WHO CoPP certification
scheme is what we have in practice and 'it has lost some of its
credibility'. We like to see more (regional) collaborations and joint
inspections in between DRAs or under e.g. stewardship of the WHO (ICDRA)
which then can also be an impulse for regional procurement systems. In
case stringent DRAs are prepared to share information and/or capacity
this would increase the shorter-term efficiency of the Suriname DRA
while working on capacity building (long term, possibly thru formal
partnership with some stronger sister-DRAs). What are the barriers
really besides statutory jurisdiction and probably confidentiality
issues?
4) We believe that PIC/s inspectors, besides harmonizing inspection
standards with the GMPs, look at product quality too; the pharmacopoeias
(formulations and drug substances) are as much as GMP an inspection tool
to assure product quality. We are not trying to have a small DRA
re-establishing efficacy and safety of well established generics. We do
think that PIC/s could - in principle - be a perfect school for smaller
DRA's especially those from developing countries.
5) We underline the proven value and importance of the WHO PQ program
like Bonface replied. Yet, more is needed and there are certain
loopholes with the list as well; it is based on a voluntary
participation, and in fact it delivers a recommendation, however strong
[for UN agencies] but with certain disclaimers (e.g. 'Inclusion in this
list does not constitute an endorsement, or warranty of the fitness, by
WHO of any product for a particular purpose, including in regard to its
safety and/or efficacy'). Such disclaimer probably allowed inspectorates
from the stringent countries to share their resources. Which of course
is all good and offers opportunities for training of smaller DRAs as
well but it can obviously not be a basis to free-ride. In addition (like
Patrick also hinted to) the list e.g. still does not specify the API
source for pre-qualified products. Then besides WHO and Unicef there
seem to be more possible intermediates because for time being there is
still a range of essential drugs outside the range of
pre-qualification... so we would like to read more about the
pre-qualification of procurement agents using sources outside the ones
listed as stringent above but providing assurances to meet the stringent
norms and standards).
Looking forward to more discussion to bring relevant 'stringent DRA,
reliance pro's and cons' on the table
Regards
Pascal Verhoeven
Pharmacist/independent consultant
Netherlands
verhoeven.pascal@gmail.com
Rob Verhage, pharmacist
HERA Pharmaceutical Consultant
Tawajakoerastraat 4
PO Box 4002
Paramaribo
Suriname
+597 438966 or +597 8561109
verhager@cq-link.sr