E-DRUG: RFI: Bioequivalence and generics registration (5)
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Dear E-Druggers,
The question of registration of any product (not just generics) goes
beyond what data are required to satisfy the requirements of safety,
quality and efficacy, but also what the capacity of the regulator is to
ensure ongoing compliance with comprehensive Good Manufacturing
Practice. That requires not only a regulatory authority with the
capacity to assess technical data presented by the applicant for
registration of a medicine, but also the ability to periodically inspect
the manufacturing plant responsible. For many smaller and less well
resourced developing countries, these two parts present different levels
of problems. This is particularly so when the medicines to be registered
are manufactured in another country and then imported into the
developing country in question.
Peter Mol has provided the technical detail of what should be the
approach used by all regulators in relation to generic registrations,
but the question now is - who should do this? Is it not feasible that
smaller/less resourced developing countries negotiate with other
developing countries that have some capacity for a process of
reciprocity? The under-resourced country could, without compromising its
autonomy and ability to procure medicines at affordable prices, then
recognise the registrations approved in the better resourced, but also
developing (hence sensitive to issues of affordability and balance),
country and, critically, rely on its ongoing GMP inspections.
Post-marketing activities (including ADR reporting and testing of
samples taken from the field) could also be co-ordinated. Regional
agreements such as this are urgently needed. In many regions, there are
existing regulators with a critical mass of technical expertise and
exerience. What is necessary is the political will to engage in
meaningful negotiations, instead of forever bemoaning the lack of
capacity or setting unrealistic standards that are invariably breached
and put patients at risk.
regards
Andy
Andy Gray MSc(Pharm) FPS
* Senior Lecturer
Dept of Experimental and Clinical Pharmacology
* Study Pharmacist
Centre for the AIDS Programme of Research
in South Africa (CAPRISA)
Nelson R Mandela School of Medicine
University of KwaZulu-Natal
PBag 7 Congella 4013
South Africa
Tel: +27-31-2604334/4298 Fax: +27-31-2604338
email: graya1@ukzn.ac.za or andy@gray.za.net
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