过去数十年间，生命科学与疾病基础研究取得了巨大成就，但并未有效转化为临床治疗急需的药物，药物研发的产出反而在不断下降。为了有效填补基础研究与新药研发间的知识鸿沟，更好的提升药物创新效率，急需医药科研人员、生物医药企业、政府管理部门群策群力，构建更为有序的药物创新生态系统。为实现未来10～15年创新药物产出翻番的目标，需要着重做好以下方面的工作：推动药物研发相关科学研究和应用技术的进展，建设临床研究网络、提升临床试验的效率，改善药品监管部门的管理、创新药物审评方式，加强各方沟通、降低药品审评的不确定性。

Stunning progress in life sciences and the biological basis of diseases has been achieved in the past several decades, but the scientific discoveries are not being translated rapidly enough into urgently needed medicines for the patients and the output of new medicines relative to investment has been falling steadily. In order to fill the knowledge gap between basic research and commercial projects and enhance the efficiency of drug innovation, a thriving ecosystem for innovation medicines and partnership comprised of academic researchers, bio-pharmaceutical industry, and regulators is in urgent need. To achieve the overall goal of doubling the output of innovative new medicines over the next 10—15 years, the following aspects of work should be focused on: to improve the scientific researches and applied technologies used for the drug development, to establish the clinical trial network and promote the efficacy of clinical trials, to strengthen the management of drug regulatory authorities and to accelerate the approval pathways used for the innovative medicines, to expand the more efficacious communication among the stakeholders, and to decrease the uncertainty in drug evaluation as well.

国家重大新药创制专项（2011ZX09401-009，2012ZX09105102）