Artimist, page-10

Hi Beale
Following on from the WHO/MMV discussions re approval from FDA and or EMA via Article 58 there may be some road blocks.
Applications to EMA for Article 58 approval can only be done by European based companies...... this counts SUD out unless the application is made by the trial sponsor and our partner in MRC namely PP..... the groans are nearly audible. The key document is the CTD which initially was going to be finalised mid year but all has gone quiet on that front. However I do expect it to have been finalised and been part of the interested partners packs. As I have only briefly skimmed through the Article 58 timelines it would appear to be up to 240 days approval but on the way there are some hold points where the day count stops. I will do more reading on the process over the weekend and try to get my head around it all.

I would also sincerely hope that with the co-operation of all parties MMW,WHO,EMA,SUDA,PP there is a fast track procedure that could be instigated.

Just as an aside the Article 58 is a means whereby the EMA can approve the use of drugs in poorer countries so long as the drugs cannot be used in European Countries. Just as well the European climate doesn't suit malaria.

Have a good weekend all.

kippax

PS I expect little action / news next week as the team returns from all parts of the globe but expect after burners to kick in from 10th November