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本帖最后由 beiwei5du 于 2017-10-9 10:37 编辑
请问，承担BA/BE的机构需要什么条件？？？国外国内是否有相应的BA/BE self-certification checklist??望分享 Bioavailability And Bioequivalence (BA/BE) Requirements Currently, the manufacturing license for established drugs (already on market for more than four years) is given by state drug administrators without any BA/BE test of the products. For better quality control, the policy makes BA/BE tests mandatory for all drug manufacturing permissions and for future renewals of manufacturing licenses for all drugs. It is to be implemented in phases so small-scale industries are not impacted upfront. Still, this is expected to raise a cry from manufacturers as it will impact the overall development cost and affordability of drugs. The industry has expressed difficulties implementing BA/BE studies for all drugs and has suggested it should be restricted to BCS Class II and Class IV drugs only. They have also suggested that relevant infrastructure (accredited BE centers and testing laboratories) must be established before implementation. The policy also states the central drug regulator shall conduct regular annual audits of laboratories accredited to conduct BA/BE tests and certify the results. Provisions for self-certification for BA/BE compliance by existing license holders would also be introduced so effective quality standards can be ensured without waiting until the time of future renewals. Self-certification of manufacturing plants based on a regulatory-driven checklist has already been initiated, and the same concept seems to be getting extended to BA/BE centers as well, which is a welcome move. 一、改革临床试验管理 （一）临床试验机构资格认定实行备案管理。具备临床试验条件的机构在食品药品监管部门指定网站登记备案后，可接受药品医疗器械注册申请人委托开展临床试验。临床试验主要研究者应具有高级职称，参加过3个以上临床试验。注册申请人可聘请第三方对临床试验机构是否具备条件进行评估认证。鼓励社会力量投资设立临床试验机构。临床试验机构管理规定由食品药品监管总局会同国家卫生计生委制定。 | 
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发表于 2017-10-9 10:35:43
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