Pharmaceutical regulatory Affairs

REGULATORY AUTHORITIES OF DIFFERENT COUNTRIES Various regulatory authorities in major developed and developing nations around the world, as well as the scope and issues these organizations face in delivering safe and effective healthcare goods. USA   Food and Drug Administration (FDA) Europe European Medicines Agency (EMEA) UK Medicines and Healthcare Products Regulatory Agency (MHRA) Sweden Medical Products Agency (MPA) Netherlands Medicines Evaluation Board Ireland Irish Medicines Board Italy Italian Pharmaceutical Agency Denmark Danish Medicines Agency Australia  Therapeutic Goods Administration (TGA)  Japan Ministry of Health, Labor & Welfare(MHLW) India   Central Drug Standard Control Organization (CDSCO) Canada   Health Canada Costa Rica Ministry of Health Nigeria  National Agency for Food and Drug Administration and Control (NAFDAC) Ukraine   Ministry of Health Singapore Centre for Pharmaceutical Administrati...

  New Drug Application It is an application filed with FDA, for a U.S. generic drug approval for an existing licensed medication or approved drug. In simple words, ―It is an application for the approval of Generic Drugs. A New Drug Application (NDA) is a comprehensive submission to the U.S. Food and Drug Administration (FDA) by a drug sponsor seeking approval to market a new drug in the United States. The NDA provides detailed information to the FDA to evaluate the safety, efficacy, labeling, and manufacturing standards of the new drug. It includes data from laboratory and animal preclinical studies as well as human clinical trials (Phase 1-4). The FDA reviews the NDA within 60 days of submission and issues one of three action letters: Approval Letter, Approvable Letter, or Not Approvable Letter The NDA's goals are to offer adequate material for FDA reviewers to make the following essential decisions: Whether the medicine is safe and effective in its intended application(s), and wh...