Regulatory evaluation of efficacy and safety of new drugs in China
Regulatory evaluation of efficacy and safety of new drugs in China
摘要
Accessibility, availability, and rational use of medicines are widely recognized priorities for guaranteeing equity in health care. Commercial pressure can twist health policy if pharmaceutical companies are allowed to promote and impose their products beyond clear public-health interest. National regulatory
参考文献3
-
1The European Agency for the Evaluation of Medicinal products.CPMP D70 assessment report templates: overview and list of questions. http://www. emea. eu. int/pdfs/human/d70ar/d70og. pdf . 2003
-
2United States Food and Drug Administration.Reviewer guidance. http:// www. fda. gov/cder/guidance/issrvg08. pdf . 2003
-
3Pandolfini C,Bonati M,Reggi V,et al.Regulatory assessment of new drugs in developing countries[].The Lancet.2003
-
1Hanan Ghantous.Safety Assessment of Biological Products A Regulatory Perspective[J].毒理学杂志,2005,19(A03):173-173.
-
2Nisha H. Parikh,Palak K. Parikh,Charmy Kothari.Indigenous plant medicines for health care:treatment of Diabetes mellitus and hyperlipidemia[J].Chinese Journal of Natural Medicines,2014,12(5):335-344. 被引量：2
-
3陈兆青.中国国家基本药物制度促进了合理用药[J].中国卫生政策研究,2016,9(2):51-51. 被引量：3
-
4美国FDA批准Bayer的Skyla^TM用于长达3年的避孕措施[J].中国新药杂志,2013,22(5):498-498.
-
5房建国.药学监护在临床合理用药中的应用[J].临床合理用药杂志,2009,2(9):77-78. 被引量：1
-
6系列问答79——如何理解“新药”的含义？[J].药物不良反应杂志,2005,7(1):74-74.
-
7Shailendra KAPOOR.Artesunate and its emerging anti-neoplastic effects:beyond its role in attenuating tumor growth in osteosarcomas[J].Journal of Zhejiang University-Science B(Biomedicine & Biotechnology),2012,13(12):1029-1030.
-
8加拿大批准Ralivia治疗中重度疼痛[J].齐鲁药事,2008,27(9):515-515.
-
9Cases analysis of rational use of medicine （8）[J].天津药学,2004,16(2):81-81.
-
10苏皖锦.赛诺菲宣布启动BEYOND系列临床研究[J].糖尿病之友,2014,0(10):92-92.
