Did you know...?
One copy of a dossier can easily contain more than 500 folders with a total of 140,000 pages. In print, this adds up to 11 palettes of paper which together weigh up to 1.7 tons.
The final sprint
If all tests are successful, the approval of the new drug can be applied for with the competent authorities. To accomplish this, a dossier must be submitted which precisely documents everything from research and development to production.
A dossier consists of five modules: module 1 contains among others the drafts for the summary of products characteristics and packet inserts. Module 2 summarises the remaining modules and presents the critical valuation reports. Module 3 contains everything on the substance and the product, for example the dosage form. The preclinical development data are listed in module 4, while the results of clinical trial phases I-III are presented in module 5.
Once all necessary information for the dossier has been compiled completely, consistently and in the right order, a time slot must be applied for with the competent authorities. This time slot is like drawing a number when waiting at public offices, since there might be similar queues. Once all of the authorities’ enquiries have been answered satisfactorily (which can take up to six months), then the new drug is approved.
last update: 11 Jan 2012