2020/04/28 15
  • 品牌国家:英国
  • 代理区域:中国
  • 代理授权证书:
  • 英国国家生物制品检定所(National Institute for Biological Standards and Control,NIBSC),英国国家生物制品及标准化控制研究所,是英国药品及卫生保健产品管理机构的枢纽与执行机构,英国生物医药检验实验室,主要的WHO国际生物制品标准实验室及WHO负责脊髓灰质炎、流感及HIV研究的协作中心,英国干细胞库,同时也是生物药制剂鉴定及其标准对照品生产供应的全球。NIBSC处于一个位于产品制造、调节、政策制定及学术前沿的独特国际位置,通过提供生物制剂标准参照品、生物制剂鉴定及相关研究确保全球生物医药制品的质量,同时也为生物医药产品的研发提供有力支持。



    We are the leading WHO Collaborating Centre and International Laboratory for Biological Standards, Essential Regulatory Laboratory (ERL) for Influenza, WHO Collaborating Centre for Reference & Research on Poliomyelitis and the WHO Global Specialised Polio Network Laboratory.

    We occupy a unique international position as the interface between:

  • product manufacturers

  • regulators

  • policy makers

  • cutting-edge academic research

  • The Institute is the UK’s Official Medicines Control Laboratory (OMCL), responsible for carrying out independent official batch release testing of biological medicines as required by EU law. 

    Biological medicines and vaccines are usually very complex materials. In order to ensure that these products are both safe and effective it is necessary to thoroughly evaluate their quality and biological activity. Each batch is examined and approved, independently from the manufacturers, and issued with a EU/EEA OCABR certificate before being released onto the market.

    Biological substances used in healthcare include bacterial and viral vaccines against diseases such as: 

  • diphtheria

  • whooping-cough

  • meningitis

  • poliomyelitis

  • influenza

  • hepatitis

  • measles

  • mumps

  • rubella 

  • They also include therapeutic products derived from human blood such as clotting factors and immunoglobulins, as well as other products such as monoclonal antibodies, hormones, cytokines and growth factors.