1MHLW. Guidelines for package inserts for prescription drug( Notification no. 606 of the PAB) [ J/OL]. http://www. mhlw. go. jp, 1997 -04 - 25.
2MHLW. Guidelines for package inserts for prescription drug ( Notification no. 59 of the Safety Division, PAB ) [ J/OL ]. http://www. mhlw.go. jp, 1997-04-25.
3MHLW. Guidelines for Precautions for prescription drug ( Notification no. 607 of the PAB) [J/OL]. http://www. mhlu. go. jp, 1997 -04 -25.
4FDA. Guidance for industry: Clinical studies section of labeling for prescription drugs and biologics -content and format [J/OL]. http://www. fda. gov, 2001 -05 -01.
5EMEA. A guideline on summary of product characteristics [ J/OL ].http://www. emea. eu. int, 1999 - 12 - 11.
6EMEA. A guideline on the readability of the label and package leaflet of medicinal products for human use[ J/OL]. http://www. emea. eu. int,1998 -09 -07.