ժҪĿ�� ���ݴ���ҩҩѧ�з��ص�,̽�ִ���ҩҩѧ�о��Ľ��Կ��ǡ����� ���ڿ�ѧ�ͷ���ԭ��,�ڽ���������ʵ���Ļ�����,�ο�FDA��EMA��������ؼ���Ҫ��,��������ʴ�����ҩ��˾���з����顣��� ����˽���ҩѧ����Ҫ��,�����Խ������Ի�ѧҩ��ҩ�ٴ�����(investigational new drug application,IND)����(�����ٴ�)ҩѧ�о���Ϣ���ܱ�/����ģ�桢��ͨ��������ȱ����ƶ�ΪҪ�ص�����ģʽ������ ����ҩ��ҩѧ�о�Ӧ��ҩ�������з�������Ӧ,��Ҫ��֤�г�ֵ��з�����֧�ַ��������ͷ��տ���,�ֲ��ܿ�Խ�з��ι��翪չ������о���
Abstract��
OBJECTIVE To discuss phase-dependent CMC requirements for innovative drugs were discussed in view of the R&D approaches of innovative drugs. METHODS Refer to FDA and EMA��s related guidance and learn from the R&D experience of the international pharmaceutical companies, on the basis of review practice and risk-based regulatory principle. RESUTLS Phase-dependent CMC requirements for innovative drugs were proposed, quality overall summary, CMC annual report system and two-way appointment-based communication were developed. CONCLUSION The breadth and depth of CMC information of innovative drugs depends, in large part, on the phase of the investigation. It��s recommended that CMC information should be enough to support risk-evaluation and risk-control, while it��s unnecessary to do too much over development phase.
ZHANG Ning,
WANG Ya-Min,
CHEN Zhen
.Considerations on Phase-Dependent CMC Requirements for Innovative Drugs[J] Chinese Pharmaceutical Journal, 2014,V49(17): 1565-1567
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2014, Vol. 49 
