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The European Medicines Agency (EMA) is an agency of the European Union (EU) that evaluates and regulates pharmaceutical goods. Prior to 2004, it was called the European Agency for the Evaluation of Medicinal Products (EMEA).The primary goal of the European Pharmaceuticals Agency (EMA) is to preserve and promote human and animal health by analyzing and monitoring pharmaceuticals across the European Union (EU) and the European Economic Area.

An abbreviated new drug application (ANDA) contains information submitted to the FDA for examination and possible approval of a generic drug product. Once approved, an application may produce and promote the generic drug product as a safe, effective, and less expensive alternative to the brand-name drug it references. It must prove that a proposed generic medicine is equivalent to an existing approved reference-listed drug (RLD) in terms of safety, efficacy, and quality.