After the State Council required rectifying and reforming the examination and approval of drugs, CFDA asks for advices to solve the backlog problem of drug registration, aiming to increase the efficiency of drug examination and approval, and solve the backlog problem of drug registration. There are several characters: To increase the efficiency of examination and approval, the drug which is not as effective as the brand-name drug shall be not approved; Enterprises are allowed to withdraw applications; Applications in mismatch conditions will be returned; Applicants will be guided to apply logically with humanized suggestions; Bioequivalence tests will be switched to filling system from examination and approval system; The examination and approval system of the drug delivery route and the change of variations will be strictly controlled, except the drugs for children; The punishment of fraud is emphasized; the examination and approval for drugs which are needed urgently by clinic will be accelerated; the backlog will be examined intensively. (Source: Chinamsr)
CFDA为解决药品注册积压征求意见，儿童药企受益显著
来源：中国医药联盟 2015-08-04
核心提示：国务院要求对药品审评审批进行整改之后，药监总局很快出台了《关于征求加快解决药品注册申请积压问题的若干政策意见》，旨在提高药品审评审批效率，解决药品注册申请积压的矛盾。《征求意见》中有几大特点：提高审批标准，没有达到与原研药质量和疗效一致的不予批准，允许企业选择撤回，退回不符合条件的申请，引导申报人理性申报，比以往的意见更人性化;生物等效性试验由审批制改为备案制;严格控制改变剂型及给药途径的审评审批，儿童药除外;强调造假行为将严惩;儿童用药等临床急需药品加快审批;集中审评积压的注册审批等。
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国务院要求对药品审评审批进行整改之后，药监总局很快出台了《关于征求加快解决药品注册申请积压问题的若干政策意见》，旨在提高药品审评审批效率，解决药品注册申请积压的矛盾。一位医药行业研究员表示，此次十条征求意见有望为儿童药企、医药CRO龙头企业等带来利好。
《征求意见》中有几大特点：提高审批标准，没有达到与原研药质量和疗效一致的不予批准，允许企业选择撤回，退回不符合条件的申请，引导申报人理性申报，比以往的意见更人性化;生物等效性试验由审批制改为备案制;严格控制改变剂型及给药途径的审评审批，儿童药除外;强调造假行为将严惩;儿童用药等临床急需药品加快审批;集中审评积压的注册审批等。
不久之前，CFDA以雷霆手段要求各药企对其药物临床试验数据进行限时自查，背后的推动力量正是国务院发话要求整改药品审评。此次征求意见的出台，也使得这一事件的后续发展脉络更加清晰，那就是在清理积压存量，退审一批药品之后，提高仿制药门槛，加快自主创新和临床急需的品种的审评。
上述研究员称，从《征求意见》不难看出，儿童药企是最明显的受益者。鼓励改变为儿童药剂型，儿童用药实行单独排队、加快审评审批，都将刺激儿童用药企业研发积极性，促进儿童用药研发将在数量和速度方面的提升。康芝药业(300086.SZ)、山大华特(000915.SZ)、葵花药业(002737.SZ)、亚宝药业(600351.SH)、济川药业(600566.SH)、健民集团(600976.SH)等儿童用药相关企业或将受益。
CFDA这一征求意见出台后，也引起资本市场的关注，多家券商对此进行点评，除儿童药企之外，优质创新型药企、优质仿制药企业以及医药CRO龙头企业也被认为迎来重大利好，如恒瑞医药(600276.SH)、复星医药(600196.SH)、华海药业(600521.SH)、海思科(002653.SZ)、泰格医药(300347.SZ)、博济药业(300404.SZ)等。
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