智通财经APP讯，康希诺生物(06185)发布公告，本公司的ACYW135群脑膜炎球菌多糖结合疫苗(CRM197载体)(MCV4)及13价肺炎球菌多糖结合疫苗(CRM197╱破伤风类毒素)(PCV13i)的生产基地通过了马来西亚药监局(NPRA)实施的药品检验合作计划(PIC/S)良好生产规范(GMP)符合性检查，并于近日获得NPRA颁发的GMP证书。
PIC/S为国际药品检查、认证的权威机构，由数十个国家的药品监管机构组成，以统一标准对人用和兽用药品的GMP实施检查、认证，GMP符合性检查是药品注册上市的必要条件之一。在自愿的基础上，PIC/S成员国及参与机构之间执行 GMP符合性检查互认。
本次通过PIC/S GMP认证，标志着本公司的生产和质量管理体系符合PIC/S GMP 的标准，将有助于推进MCV4、PCV13i在马来西亚及其他PIC/S成员国药品注册上市的工作。
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