Dossier submission process of drug product in USA, Europe and India (e-book) (used book) | bookbook.eu

Description

Dossier is a file document submitted based on the requirement of regulatory agency for the approval of drug product. It is essential to submit dossier file in the form of common technical document in USA and EUROPE. Generic drugs are approved under ANDA submission. An Abbreviated New Drug Application (ANDA) is an application for a U.S. generic drug approval for an existing licensed medication or approved drug.The ANDA contains data which when submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public.The European Medicines Agency (EMA) is a European agency for the evaluation of medicinal products.The EMA operates as a decentralized scientific agency of the European Union and is responsible for the protection and promotion of human and animal health, specifically through the coordination of evaluation and monitoring of centrally authorized products and national referrals, developing technical guidance and providing scientific advice.