Project Management Of Technology Transfer For Drug Products

In recent years, the majority of the world’s pharmaceutical companies are facing patent expiration of drugs, the increasing of drug development difficulty, the low success rate, slow progress and other issues, most of the world’s pharmaceutical giants take the technology transfer to approach to reduce costs to maintain profit margins. Most of these patented drugs are produced in Europe and other developed countries, moving the production to the low cost developing countries to improve net profits. China has a large pharmacy scale, low cost and a huge potential pharmaceutical market and other advantages, which is becoming a paradise for technology transfer. World Health Organization (WHO) and the International Society for Pharmaceutical Engineering (ISPE) published a guide about drugs technology transfer. Currently, there is not a mature and complete guidance documents and practical guidance about drugs technology transfer. This paper, by analyzing the domestic and international technology transfer status differences, applies schedule management and risk management tools of project management to process management of technology transfer, and combines with transfer experience of large multinational pharmaceutical companies in the field of pharmaceutical technology, sets up scientific drug technology transfer model, identifies of drug risk points in the process of technology transfer, and formulate the corresponding risk reduction measures, to ensure the project smoothly and GMP certification through the market and the market access, and make sure the companies can control cost scientifically, and ensure product quality stability. Through this study, drug technology transfer model putting forward in this paper can be hoped to implement product transfer project for our pharmaceutical enterprises, and help more Chinese pharmaceutical enterprises to adapt to market demand, towards the international market.