Abstract
China has recognized the importance of establishment of a legal framework for chemical safety management and made remarkable progress in recent years. SFDA, the state drug authority, has took necessary steps to meet its goal of globalization and promulgated regulations, standards procedures and guidance in safety evaluation and administration of pharmaceutical and medical devices. The Ministry of Environmental Protection has promulgated the amended Measures on Environmental Management of New Chemical Substances (MEP Order No 7) which came into force from October 15th, 2010. Other guidance has been issued since in supporting of the execution of this regulation. Pesticide safety evaluation and registration system has also been further standardized including certify toxicology/environmental testing laboratories under new rules. The Decree 591, another regulation on safety management of dangerous chemicals had been promulgated by the state council and took effect on the 1 December 2011. This keystone regulation opens a new era for chemicals control in China to convergence with REACH, GHS on dangerous chemical control. In general, these are China’s efforts to the format of US, OECD and other international standards. However, there are indeed some philosophical, technical and practical differences between China and rest of the world, giving the considerations of current situation in China.
This presentation will give an introductory overview of the Chinese regulatory framework of safety evaluation, risk assessment and management in comparison with US and other international standards in regulations, procedures and guidelines. In addition, the presentation will also discuss the new changes and trends in regulatory field in China. Finally, the talk will discuss the challenges and opportunities with personal experience both in the US and China.
