The Special Rules stipulate additional requirements which help supplement existing laws, rules and regulations and clarify legal obligations in pharmaceutical, food, cosmetic, medical devices, Chinese medicine, and other health related product supply chains.
The Special Rules were promulgated in 2007 after scathing criticism was leveled at China by both domestic and international intersts due to China’s long history of product quality and safety issues. The Special Rules were designed to essentially fill in the cracks and loopholes left by other laws and regulations and to cohesive management of consumer product safety and quality. China has a comparatively complete legal system governing the scope of what would normally be defined as consumer goods. This legal framework consists of 11 laws and 22 regulations including Food Hygiene Law, Law on Quality and Safety of Agricultural Products, Product Quality Law Pharmaceutical Administration Law, Regulation on the Administration of Hog Slaughter, Regulation on the Administration of Animal Feed and Feed Additives, Regulation on the Implementation of Food Safety Law and Regulation on the Hygiene Supervision over Cosmetics and the Regulation on the Implementation of the Food Safety Law etc. Nevertheless, despite the strong legal foundation provided by these laws China’s regulatory authorities have underperformed in terms of their enforcement, supervision and oversight on almost all links in the associated supply chains. The special rules also provide regulatory authorities with a useful tool to help realize an improvement in product quality and safety.