Monday , 26 February 2024

Assessment of Regulatory Requirements and Filling Procedure of Drug Master File for Brazil, Europe, and India, USA and Australia

M.N. Shankarananda*1, K. Sunil Kumar2
1Department of DRA, Sun Institute of Pharmaceutical Education and Research, Kakupalli, Nellore, Andhra Pradesh, India.
2Associate Professor, Department of DRA, Sun Institute of Pharmaceutical Education and Research, Kakupalli, Nellore, Andhra Pradesh, India.

A B S T R A C T
For a new drug, the FDA commits to reviewing most NDAs/BLAs within a total of 12 months. Once a drug is initially approved to treat a specific population or indication, applicants may conduct additional clinical studies to support subsequent FDA approvals in other settings (e.g., in another line of therapy), in combination with other treatments, or in other diseases. For a subsequent marketing application for additional use of an approved drug, the appropriate nonclinical and CMC data may have already been reviewed by the Agency in the initial application; as a result, supplemental marketing applications typically contain less data. Accordingly, the FDA aims to review supplemental applications within a total of 10 months. The study aims to assess the regulatory requirements and filing procedure of drug master file for brazil, europe, India, USA and Australia. New drugs begin in the laboratory with scientists, including chemists and pharmacologists, who identify cellular and genetic factors that play a role in specific diseases. They search for chemical and biological substances that target these biological markers and are likely to have drug-like effects. The Drug approvals in the India, Europe & US are the most thought due in the world. The primary purpose of the rules governing medicinal products in India, Europe & US is to safeguard public health. It is the role of public regulatory authorities to ensure that pharmaceutical companies comply with regulations.

Keywords: FDA approvals, brazil, europe, India, USA and Australia, medicinal products, Public health.

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