Brief Introduction and Implication of the Package Leaflet Readability Guidelines of FDA and EMA

Abstract

Abstract: Objective To introduce the readability guidelines of package leaflet in FDA and EMA, and put forward suggestions on developing labelling readability of China. Methods Literature study were used to analyze the foreign materials, and contrast the differences between China and them. Results There is a big difference between foreign countries and China on labelling content and effect after readability tests of package leaflet. Conclusion s We should learn achievement from FDA and EMA to improve readability of labelling.

Key words: readability, OTC, package leaflet

CLC Number:

R951

TANG Ren, WANG Xiao-yan, YANG Yue . Brief Introduction and Implication of the Package Leaflet Readability Guidelines of FDA and EMA [J]. Chinese Journal of Pharmacovigilance, 2013, 10(8): 464-467.

References

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