NATIONAL ASSEMBLY
FOR WRITTEN REPLY
QUESTION NO. 646
DATE OF PUBLICATION IN INTERNAL QUESTION PAPER: 15 March 2010
(INTERNAL QUESTION PAPER NO. 7)
Mrs C Dudley (ACDP) to ask the Minister of Health:
(1) Whether he has been informed that a regulation backlog of nearly 3
000 medicines, which could take another two years to resolve, is being
exacerbated by the Medicines Control Councilâs (MCCâs) current
practice of duplicating tests already conducted in advanced countries;
if not, why not; if so, what are the relevant details;
(2) whether his department has considered the need for measures to ensure
the MCC can automatically accept medication already subjected to
stringent regulatory registration elsewhere; if not, why not; if so,
what are the relevant details;
(3) whether his department has considered the need for new technologies
for on-the-spot detection of fake and substandard regulated products
to protect the citizens; if not, why not; if so, what are the relevant
details?
NW772E
REPLY:
(1) Yes. We are aware of the backlog of 1 682 medicines, 45 of which are
New Chemical Entities (NCEs) and the balance generics. We define the
backlog as outstanding registrations from 2007 and prior.
The main cause of the backlog is over-reliance on external evaluators
who have primary jobs elsewhere. I have appointed a team to deal with
the backlog. I am also working on legislative amendments that will
facilitate a shift from over-reliance on external evaluators to
building in-house capacity particularly for the evaluation of generic
medicines. This legislation will also enable the regulatory authority
to retain fees, therefore facilitating recruitment and retention of
both in-house staff and external evaluators on a retailer basis.
It is true that efficiencies could be gained through entering into
formal agreements with identified stringent Regulatory Authorities.
This option forms part of the envisaged legislative review. I however
wish to advise that NRAs in developed countries mainly evaluate NCEs
and Biotechnologies, rather than generics. Further, the sources of
generics are by and large different from our applicants.
Further, the risk/benefit ratio of a medicine for a particular
population remains the responsibility of a national regulatory
authority. Speed of processing applications must therefore be balanced
with capacity building.
It is against this background that I believe the backlog will be
addressed within a year. We admit efficiency should be improved. It
should however be noted that some of the delays are due to incomplete
information and inappropriate data submitted by applicants.
(2) As indicated above, automatic acceptance is not desirable. An
abbreviated review process is however a viable option.
(3) The Department of Health, Sub-Directorate Law Enforcement, has in the
past considered a number of new technologies for the on-the-spot
detection of substances contained in medicines by using infra red
technologies. Due to the costs involved with the purchase of these
devices (in the region of R650 000 per unit excluding maintenance and
calibration costs), the Department has opted not to purchase these
devices.
Currently the Department is investigating the use of mass
spectrophotometers, a technology that compares well with infra red
technology but which may be more affordable.
END.