Research On The Use And Analysis Of Project Management In The Generic Drugs Research And Development

During 2011 to 2015 more patents of brand-name drugs will be expired which amount is about $77 billion. That means the growth speed of generic drugs market is 10% to 15% per year, far higher than the pharmaceutical industry overall development speed. At the same time, as an ageing of population, improvement of life quality, continues development and application of new drug, health care spending in every country increased year by year and the medical treatment charge can't reduced significantly. The method to control medical expenditure of the countries all over the world is to control the drug price and the main means is the promotion of the Generic drug.Due to the domestic generic drugs market competition between Chinese traditional medicine enterprises homogeneity, repeating of the production is very serious, and along with the national drug supervision to be increased, the development process of the generic drugs management work must be strengthened, it can improve R&D efficiency and shorten the development cycle, and the quality and quantity of the R&D work can be guaranteed. This dissertation introduced the generic drugs in development project management method, and combined with QbD, CRO etc. of the medical R&D theory and the management mode to set up a kind of generic drugs R&D mode which schedule and quality both important, scientific, and consistent with the needs of long term strategic development for pharmaceutical enterprise. It can improve R & D efficiency and shorten the development cycle, and the quality of the final production can be protected effectively, conformed which China's State Food and Drug Administration has been emphasizing the drug development principles "Quality controlled, safe and effective". Finally, methods for strengthen the communication management to avoid the risk of schedule delay in generic drug R&D project is advisedThe progress of the domestic's generic drugs R&D, although the introduction of foreign advanced management methods of project management and Pharmaceutical R&D concept, still require a combination of specific practical problems of domestic, local conditions, the times, to face the opportunity and challenges of the rapid development of the generic drugs market.