The eligibility criteria for EMA (European Medicines Agency) approval require a medicinal product to demonstrate safety, efficacy, and quality through rigorous clinical trials. Applicants must submit comprehensive data, including preclinical and clinical study results, to prove the product’s benefits outweigh its risks.
The product must be manufactured in compliance with Good Manufacturing Practice (GMP) standards. For orphan drugs, the condition must affect fewer than 5 in 10,000 people in the EU. EMA also assesses environmental risks and requires a risk management plan for post-approval monitoring.
