我国药物临床试验发展面临的机遇与挑战及政策建议

杨钊;黄蓝;武志昂

【期刊名称】《中国新药杂志》

【年(卷),期】2013(022)014

【摘要】随着新药研发成本的不断攀升和发展中国家市场的不断扩大,全球临床试验发展的重心正向发展中国家转移,中国周边国家纷纷积极应对,处于医药发展转型时期的我国在面对庞大机遇的同时也面临严峻的挑战.本文以全球临床试验发展趋势为切入点,结合目前国内新药研发现状和政府监管特点,分析未来我国该领域发展所面临的机遇和挑战,并在此基础上根据具体国情提出针对性的政策建议.%With the growing of the cost of IND and the expansion of the market in developing countries,the global development trend of clinical trials is transferring to developing countries day by day,and all the countries around China respond positively.Thus,China is facing a lot of opportunities and challenges at the same time.Based on the national development trend of clinical trials and the characteristic of government regulations,we analyzed the potential opportunities and challenges and then put forward pertinence suggestions.

【总页数】6页(1619-1624)

【关键词】药物临床试验;行业发展趋势;机遇和挑战;国内外现状;应对措施和建议

【作者】杨钊;黄蓝;武志昂

【作者单位】沈阳药科大学工商管理学院,沈阳110016;沈阳药科大学工商管理