The Provisions are to promote the use of the adopted name of the drug in China, requiring that the adopted name in China must be clearly marked on drug packaging and the size of each character of trade name shall not exceed half of the adopted name in China and comply with strict and detailed requirements for the positions, fonts and background colors. Registered trademark, if applicable, shall be printed in the corner of the label and the size of each character of the registered trademark shall not exceed one fourth of the adopted name in China. Particularly, the Provisions prohibit any unregistered trademark or drug names that have not been approved by SFDA from being used in drug insert sheets and labels.

The Provisions require that drug insert sheets shall contain critical scientific data, conclusions and information on the safety and effectiveness of the drug to guide the safe, rational drug use by consumers. Drug insert sheets shall provide full information on adverse drug reactions. Drug manufacturers shall revise drug insert sheets according to postmarking evaluation of the safety and effectiveness in a timely way and provide sufficient information about adverse drug reactions. Otherwise, the manufacturers will be held responsible for any adverse consequences. The Provisions also require that even the smallest packaging unit of drugs for selling shall bear insert sheets.

Drug manufacturers can also take the initiative to mark warnings on drug insert sheets or labels. Similarly, SFDA can demand drug manufacturers to mark warnings on insert sheets or labels to ensure public health and rational drug use.

The Notice requires that the use of drug trade names shall strictly comply with Provisions for Drug Registration. Except for those drugs with new chemical structures or new active ingredients and patented chemical compound drugs, other products can't use trade name. Manufacturers should use the same trade names to identify their drug products with the same ingredients in different dosage form or strength. Trade names should not be independently used in drug advertisements. Character type trademarks that have not been approved to be trade names also are not allowed in drug advertisements. SFDA will soon organize national campaigns to further standardize the use of drug names.

Provisions for Drug Insert Sheet and Label will take effect as of June 1, 2006. According to the Notice, the names and trademarks of newly registered drugs shall be used in accordance with Provisions for Drug Insert Sheet and Label from June 1,2006.  SFDA will not approve the applications of trade names not complying with the new rule even though the applications have been accepted.