药品监管事务:简要回顾

Dhananjay D. Chaudhari, Mohit R. Koli
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引用次数: 0

摘要

药品监管事务是医药行业的重要组成部分。与往常一样,制药行业发展非常迅速,需要监管事务专家来满足当前行业对全球竞争的需求。药品监管事务专家是制药行业与世界各地监管机构之间的重要纽带。药品产品审批应是确保药品生产过程安全有效的重要步骤。印度中央麻醉品管制组织(CDSCO)决定对人用药品注册的技术要求采用CTD格式。CTD的实施预计将大大减少工业界准备全球注册申请所需的时间和资源。本文通过药品监管问题的演变、作用和关系在制药行业的应用,以实施CTD指南来规范和改善药品营销行业的发展
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Drug Regulatory Affairs: Short Review
Drug regulatory affairs are an important part of the pharmaceutical industry. As usual The pharmaceutical industry is growing very fast, and there is a need Regulatory affairs experts to meet current needs industry for global competition. Drug Regulatory Affairs Specialists are an important link between the pharmaceutical industry And regulatory agencies around the world. Drug product approval Should be an important step to ensure that the process is safe and effective Drug. Central Narcotics Control Organization (CDSCO), India Decided to adopt the CTD format for the technical requirements for Registration of medicinal products for human use. Implementation CTD is expected to significantly reduce the time and resources required By industry to prepare applications for global registration. In this article Evolution of Drug Regulatory Issues, Roles and Relationships in the Pharmaceutical Industry to implement CTD guidelines to regulate and improve drug marketing industrial development
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