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Investor2014

01/17/24 2:53 PM

#448217 RE: boi568 #448215

The evaluation of medicines, step-by-step

Overall, the assessment of a new medicine usually lasts around a year.


This first evaluation lasts up to 120 days. The evaluation is then paused (first clock-stop) while the applicant prepares the responses to the CHMP's questions and updates the medicine's risk management plan. The developer generally has three to six months to answer the list of questions.


Another clear overview from EMA, but of course bas must stick to his paid PUMP and DUMP script.