Asian Journal Of Social Pharmacy

Abstract: Objective To study the process and trend of regulatory mode for pharmaceutical package materials so as to put forward some suggestions for the sustainable development of this industry. Methods Main changes of the regulatory reform of pharmaceutical package materials in China were analyzed to provide the regulatory mode for pharmaceutical package industry in the future. Results and Conclusion With the marketing authorization holder (hereafter referred to as MAH) of pharmacy as the main body, the regulation of pharmaceutical package materials will change from registration only to the comprehensive regulatory mode of MAH, authorities and the third party taking part in, which will help package material manufacturers continuously improve the level of quality management, enhance their innovation ability and improve the competitiveness in the international market.

Key words: pharmaceutical marketing authorization holder, pharmaceutical package material, association review