The CHMP review process typically involves several steps:
Submission of Application: The pharmaceutical company submits a marketing authorization application, including all relevant clinical trial data. Initial Evaluation: CHMP assesses the application for completeness and scientific rigor. Scientific Discussion: Experts in various fields, including oncology, pharmacology, and toxicology, discuss the data. Opinion Formation: CHMP forms an opinion based on the scientific evidence and may request additional data if needed. Final Decision: The European Commission makes the final decision based on CHMP's opinion.
