摘要
十二五规划以来,仿制药一致性评价受到医药行业的高度关注,其专业范围覆盖药学、临床医学、药物经济学、统计学、法学等。在对自制制剂与参比制剂的前期调研、质量评价及再研发过程中,仿制药企业无可避免地需要面对知识产权问题。为更好地提高仿制药质量与疗效的一致性,药品标准呈现由避免专利的普通技术规范向包含一定专利技术的方向发展的趋势。本文就知识产权对仿制药一致性评价中信息调研、品种评估、标准研究的影响及制药企业与相关政府部门对数据库建立、知识产权保护制度学习、技术提高方面应对措施进行综述。
Since the implementation of the Twelfth Five-Year Program, the evaluation of genetic drug consistency has attracted much attention from the pharmaceutical industry, which covers pharmacy, clinical medicine, pharmacoeconomics, statistics, law and so on. In the preliminary investigation and quality evaluation of self-made preparation and reference preparation, it is inevitable for manufacterers to face the intellectual property tight. The drug standards turned from the general technical specifications that avoided the patent. To some patented technology. This article reviews the influence of intellectual property on the information collection, variety assessment, and standard research on the consistency of generic drugs evaluation, and the counter measures pharmaceutical companies and relevant government departments taken to build the database, protection systems of intellectual property rights and technology improvement.
作者
殷德静
吴涓
YIN De-jing1, WU Juan2(1. School ofBiotechnology, Jiangnan University, Wuxi Jiangsu 214000; 2. School of Pharmacy, China Pharmaceutical University, Nanjing 21000)
出处
《中南药学》
CAS
2018年第7期1034-1036,共3页
Central South Pharmacy
关键词
仿制药
一致性评价
知识产权
药品标准
genetic drug
consistency evaluation
intellectual property
drug standard
