Exploration of the Implementation Path of Patent Standardization in Pharmaceutical Industry by Learning from the Experience of Electronic Communication Industry / 中国药房

ABSTRACT

OBJECTIVE:To provide reference for developing the implementation path of patent standardization for pharmaceuti-cal industry. METHODS:For the situation that pharmaceutical industry is still in the exploratory stage and lacks of viable experi-ence,the mature experiences of electronic communication industry in patent leading standardization implementation,authoritative organizations helping implementing patent standardization and industry alliance to promote the development of patent standardiza-tion were used as reference,combining with standard development cycle,trying to develop the implementation path of patent stan-dardization that met characteristics of pharmaceutical industry. RESULTS & CONCLUSIONS:The implementation path of patent standardization for pharmaceutical industry was divided into standard formation stage,promotion stage and upgrade stage. The main path in each stage was from patent to registration standards officially formed,guiding by policies and regulations of Food and Drug Administration to conduct standard promote by drug generation,and upgrading the drug standard by patent replacement.