E-DRUG: Planned Change from Stringent Regulatory Authority (SRA) to ˜WHO Listed
Authority
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[We look forward to some clarification about what this change means. BS}
What is in it for developing countries?
It is reported that the World Health Organization is planning to replace
the term Stringent Regulatory Authority (SRA), which is a term used to
refer to a regulatory agency that fulfill some rigorous performance
standards, with that of 'WHO Listed Authority' (WLA).
Is this simply a swapping of names or is there a tangible plan coming along
with it to change the situation in countries where there is no regulator at
all or there is a regulatory agency whose competency is too poor to be
included in WLA. And that the population is having a double burden of lack
of access to good quality essential medicines due to infiltration of the supply chain by poor quality medicines?
E-DRUG: Planned Change from Stringent Regulatory Authority (SRA) to WHO Listed
Authority (2)
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I had the opportunity and privilege, courtesy of my National Drug Regulatory Authority, to attend the recent ICDRA Conference in Dublin, and participated in the session where we received briefing on this subject.
One of the issues which struck me, and which I raised during the ensuing discussions, was the deletion of the word "Regulatory" from the new phraseology. It may well be a semantic matter but, in my view, rather ominous!
Anyway, I agree with our moderator - let us watch this space and be ready to fully contribute to the developing conversation.
Murtada M. Sesay
Health Supply Matters Ltd.
Freetown
Sierra Leone
Murtada Sesay <kindiatown@hotmail.com>
E-DRUG: Planned Change from Stringent Regulatory Authority (SRA) to WHO Listed Authority (3
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I would like to echo the concerns raised by my country-man and learned colleague , Murtada Sesay as well as sentiments expressed by Hailu Tadag of USP-Ethiopia.
I hope the planned change of the term-"Stringent Regulatory Authority" to "WHO Listed Authority" is not just a matter of semantics, optics or political correctness but will usher a new era in which there is a well defined path for attaining the status of
"WHO Listed Authority"
In the past, the path to stringency was nebulous at best and unfair at worst. We have witnessed the elevation of certain country regulatory authorities to the prestige status of Stringent regulatory authority by merely belonging to a political pact such as the European union and by definition, an ICH member which makes their regulatory authority "stringent".
Some of us have long advocated for a more transparent, fair and structured path toward regulatory stringency. It is only but fair that country regulatory authorities which have been at the receiving end of rigorous and prolonged technical assistance start to demand a path toward stringency so that they not only receive the recognition of progress made but will benefit from attaining such a status including global recognition of market authorization of products approved by such bodies and all the benefits that go with it.
Otherwise it is business as usual- more technical assistance, ad infinitum with no sunset criteria and nothing to show for it. Yet we see country staff conduct dossier reviews on behalf of WHO outside of their home countries resulting in product approvals but yet their own institutions continue to be labelled as lacking capacity. If there are institutional constraints that prevent these competent staff from doing the same work in their home countries as they do in Copenhagen, then we should identify those constraints and address them. There may very well be institutional inadequacies that prevent competent people from doing good work at home, otherwise I do not see how you can be competent abroad and incompetent at home.
Therefore, the proposed name change is a welcome news provided it recognizes current realities in the regulatory space and seeks to create a structured and transparent path to "stringency" or "WHO Listed Authority" status.
I rest my case for now, hoping to follow the progress of this very closely.
Patrick Lukulay, Ph.D.
President, Tech4Health Ltd.
phl@tech-4health.com
Accra, Ghana
PATRICK LUKULAY <plukulay@hotmail.com>
E-DRUG: Planned Change from Stringent Regulatory Authority (SRA) to WHO Listed Authority (4)
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In common with the previous comments on this subject, I can see why WHO
would want to tidy up what currently seems to be a two-tier situation
favouring high-income countries, but with little or no opportunity for
promotion to the stringent level for other regulatory authorities. But
like Murtada Sesay (message 2) I find it very strange to drop the word
"Regulatory" from the description.
We need to hear more from WHO on the thinking here.