What are the key responsibilities of EMA in the context of neonatal disorders?
The EMAâs responsibilities in the context of neonatal disorders include:
Scientific Evaluation: The EMA evaluates the safety, efficacy, and quality of medicines intended for neonatal use. Guideline Development: The EMA develops guidelines for clinical trials involving neonates to ensure that studies are conducted ethically and scientifically. Safety Monitoring: The EMA monitors the safety of neonatal medicines through pharmacovigilance activities to identify and manage potential risks. Regulatory Support: The EMA provides support to pharmaceutical companies during the drug development process.
