Rapid Retrieval Approach of Original Drugs Information for Generic Drugs
ZHU Feng-chang1, WANG Xiao-jing2, WANG Ai-guo1,3, ZHANG Hua-ji1, JIANG Yi-guo4, CAO Xiu-ping1, YANG Chun-ning1, GUO Shuang1, WANG Lei1, DING Li-xia1*
1. Chinese Pharmaceutical Association, Beijing 100050, China;
2. Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100050, China;
3. Center for Information, NMPA, Beijing 100044, China;
4. The Affiliated Suzhou Science and Technology Town Hospital of Nanjing Medical University, Suzhou 215153, China
OBJECTIVE To introduce some famous international pharmaceutical databases, analyze and summarize the information of generic drugs, retrieve and determine the original drug information, and to explore a rapid and feasible method for searching the information of the original generic drugs, which provide reference and assistance for the consistent evaluation of the quality and efficacy of generic drugs in China. METHODS The original drugs information of generic drugs were analyzed and summarized from famous international pharmaceutical databases and websites, such as Yaozhi.com database, Pharmaprojects database, Thieme Pharmaceutical Substances database, and Thomson Reuters Integrity database, and FDA Orange Book, and the original drug information was determined. The rapid approach of retrieval original drugs information for generic drugs was explored by compare the difference to the database and website. RESULTS The rapid and feasible retrieval and determinable approach of the original drugs information for generic drugs was established, and the original drugs information of 49 drugs specifications of the first batch of evaluation without reference listed drug/reference standard(RLD/RS) preparation filing was successfully retrieved and preliminarily determined. CONCLUSION The established retrieval approach of the original drugs information for generic drugs is rapid and feasible, and aiming to provide reference for the selection of RS, and provide help for the follow-up study of original research information of generic drugs to be conducted.
GENERAL OFFICE OF THE STATE COUNCIL. Opinion on carrying out the quality and efficacy consistency evaluation of generic drugs[EB/OL]. (2016-03-05) [2020-08-20]. http://www. gov. cn/zhengce/content/2016-03/05/content_5049364. htm.
[2]
NMPA. Notification on issuing the selection and determination procedures of RLD for generic drugs[EB/OL]. (2019-03-25) [2020-08-20]. https://www. nmpa. gov. cn/xxgk/ggtg/qtggtg/20190328162401710. html.
[3]
YAO Z H(药智网)[DB/OL]. [2021-03-20]. https://www. yaozh. com/.
[4]
CHEN G, CHEN D H, TONG Y. Pharmaprojects database and retrieval approach [J]. J Shenyang Pharm Univ (沈阳药科大学学报),2003,20(1):75-78.
[5]
GE T. Pharmaprojects web database and its application[J]. Prog Pharm Sci (药学进展),2011,35(12):75-78.
U. S. FDA. Orange Book: Approved drug products with therapeutic equivalence evaluations [EB/OL]. [2021-03-20]. https://www. accessdata. fda. gov/scripts/cder/ob/index. cfm.
[11]
Japanese Orange Book[EB/OL]. [2021-03-20]. http://www. jp-orangebook. gr. jp/cgi-bin/search_h/search_e.cgi.
[12]
EMA. Science Medicines Health[EB/OL]. [2021-03-20]. https://www. ema. europa. eu/en/medicines?search_api_views_fulltext=.
[13]
GUAN H Y, SUN H S, LIN J, et al. Discussion about the selection of generic drugs consistency evaluation reference medical product[J]. Chin J New Drug(中国新药杂志), 2018, 27(20):2397-2399.
2021, Vol. 56 
