NATIONAL ASSEMBLY
FOR WRITTEN REPLY
QUESTION NO. 1854
DATE OF PUBLICATION IN INTERNAL QUESTION PAPER: 29 July 2011
(INTERNAL QUESTION PAPER NO. 20)
Mrs J F Terblanche (DA) to ask the Minister of Health:
Whether, with reference to his reply to question 1835 on 18 July 2010, any progress has been made in reducing the number of applications before the Medicines Control Council (MCC) with regard to (a) new chemical entities (NCEs), (b) generics and (c) complementary medicines; if not, why not, in each case; if so, (i) what is the current backlog in each case and (ii) how many applications have taken longer than (aa) six months, (bb) one year, (cc) two years and (dd) three years?
NW2091E
REPLY:
The backlog has not been fully cleared, progress is as follows:
(a) NCE - 37 were registered
(b) Generics - 391 were registered
(c) Complementary Medicines are currently not registered.
(i) The backlog on NCEs is 35, seven of which are ready to serve at the next MCC meeting.
The backlog on generic medicines is 1101. Of these:
25 are biosimilars that were submitted as generic medicines and applicants have been requested to provide additional clinical data.
52 are finalised on technical data but the manufacturing sites are GMP negative.
6 have been finalised on technical data but the names have not been approved.
8 have been rejected.
(ii) The following table reflects the details
|
REGISTRATION TIME |
NCE |
GENERIC |
TOTAL |
|
More than 6 months |
1 |
1 |
2 |
|
More than 1 year |
4 |
19 |
23 |
|
More than 2 years |
7 |
126 |
133 |
|
More than 3 years |
25 |
245 |
270 |
|
TOTAL |
37 |
391 |
428 |
Issued by Parliament, September 19 2011
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