欧盟生物类似药注册要求的风险管理计划

Risk Management Plan of Biosimilars Registration Requirements in European Union

讨论生物类似药上市申请中的安全性监测要求,描述在风险管理计划中应该开展的工作,根据欧盟的法规提交风险管理计划和药物警戒系统。风险管理计划包括:安全性规格;药物警戒计划;对于药物风险最小化工作需要的评价;风险最小化工作;欧盟风险管理计划的概要。在风险管理计划中,应该考虑对于参照药或产品类型应用的任何安全性监测,并说明药品上市后的追踪计划及风险处理方案。

The paper disccused biosimilars safety monitoring requirements of the marketing authorization application and describes the activities that should be developed in their risk management plan（RMP）. RMP and pharmacovigilance system should be provided in accordance with EU legislation. The RMP should include：safety specification, pharmacovigilance plan; evaluation of the need for risk minisation activity, risk minisation plan;summary of the EU-RMP. Any safety monitoring imposed on the reference produc or product class should be in the RMP.