It is known SFDA have finished the revised edition of GMP standards, and it is hoped new GMP standards will be issued the second half year. Different with the requirements for hardware facility in first round GMP compliance, the second round GMP compliance will focus on software aspect and the purpose is to boost R&D.
Through first round GMP compliance, Chinese GMP pharmaceutical enterprises mostly realize production automation, and the whole level of Chinese pharmaceutical enterprises go up to a new step. But during the construction process of GMP hardware, the scarcity of innovation capacity becomes the main block to enterprise's survival and development. The effective implement of new GMP will boost the regulation of product structure，R&D of new product and enterprise's core competence.