Technical Transfer Study Of Pharmaceutical Products

There will be 77 billion USD pharmaceutical products off patent which are mainly manufactured in developed countries in Europe and American. It will pressurize global pharmaceutical enterprises to move to low cost supply by transfer the products to low cost supply source. China is a good choice for low cost supply due to resource and cost advantage. However there are great differences between China and developed countries in Europe and American, from regulatory requirement, ie GMP(Good Manufacturing Practice), EHS (Environment, Health, Safety) requirement regulatory authority inspection/audit. It is a huge challenge for China local pharmaceutical products to meet the requirement and have pharmaceutical products successfully transferred to China and then successfully export and sell to the developed countries in Europe and American, while there is no reference available in China to guide the pharmaceutical products and technical transfer.In this article, by analyzing the GMP requirement, EHS requirement and regulatory authority site inspection between China and Europe/American, and studying successful product technical transfer in a few global pharmaceutical enterprises and analyzing their best practice as reference, such as Glaxo SmithKline has successfully transferred 3 products with more than 100 SKUs from Europe, Canada and Australia to China, and successfully launched finished products to about 50 markets in Europe, America, Africa, Australia and Asia. developed a practical guidance for pharmaceutical product technical transfer, particularly for China local pharmaceutical enterprises, including assessment of the feasibility, plan, compile knowledge, implement analytical transfer, technical transfer, regulatory registration and site GMP audit, supply chain set up and transfer, and launch in the market.It provides guidance to local pharmaceutical companies during product transfer from to Europe & American to China during the journey to be a global supplier especially to the developed countries.