Overview in EMA and FDA Approved Novel Drugs in the Years 2020, 2021 and 2022.
DOI:
https://doi.org/10.54361/Ljmr18-1.18Keywords:
European Medicine Agency, drug approval, Food and Drug Administration, novel drugs, regulatory bodiesAbstract
Introduction: the drug approval is essential to any drugs to get in the market for use by patients. The current overview have been focuses on novel drugs approvals by European medicine agency (EMA) and food and drug administration (FDA).Objective: The researchers have been focused on the different between the EMA and FDA novel drugs approval during three years. Method: Throughout extracts the data from EMA and FDA and other sources and analyze the results like orphan drugs, dosage form, number of approvals, route of administration, pharmacotherapeutic class of novel drugs in both agencies.Result: In 2020, the EMA and FDA approved 39 and 53 new drugs, respectively. In 2021, the EMA approved 54 drugs, while the FDA approved 50 drugs for 2022 EMA approved 41 drugs, while the FDA approved 37. For orphan drug designation FDA had higher orphan designation than the EMA, in term of route of administration the vast majority of FDA approved drugs were parenteral drugs.Over the last three years. On the other hand, EMA approved parenteral drugs were also the highest percent. Likewise in terms of dosage form, the solid dosage forms in both EMA and FDA had the upper hand except for 2021 in the FDA. in the pharmacotherapeutic class of the EMA and FDA show high percent of antimicrobial agents, antineoplastic agents, and endocrine agents. Conclusion: The drug approval processes of the EMA and FDA exhibit similarities and differences. This Variations highlight the distinct regulatory considerations and priorities of each agency. Understanding these factors is vital for company, healthcare providers and general knowledge
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