EMA Clarifies Reexamination Process for Pediatric Trial Plans

International Pharmaceutical Regulatory Monitor
A A
Drugmakers should notify the European Medicines Agency within 10 days of receiving an initial opinion on a pediatric investigation plan if they plan to request another review. The official request, due 20 days later, should include the procedure number and a detailed justification for requesting the reexamination, according to updated guidance issued Jan. 22.

To View This Article:

Login

Subscribe To International Pharmaceutical Regulatory Monitor