[201207中国-欧盟药品质量相关法规研讨资料]MHRA第三国GMP检查.pdfVIP

Workshop on GMP/Pharmacopoeia/APIs Beijing 11-12 July 2012 GMP Inspections in Third Countries by EU Member States Gerald W Heddell Director Inspection, Enforcement Standards Division Medicines Healthcare products Regulatory Agency © GMP/药典/APIs研討會 北京2012年7月11-12 日 由成员国进行的第三国GMP检查 Gerald W Heddell Director 检查, 执行 标准部 英国药品和医疗产品监督局（MHRA ） © 34 MHRA – Our Mission The MHRA’s mission is to enhance and safeguard the health of the public by ensuring that medicines and medical devices work and are acceptably safe © MHRA – 我们的使命 MHRA的任务是通过保证药品和医疗器械有效且安全可控， 以强化和保障公众健康 © 35 MHRA’s Regulatory Functions Clinical Trials Authorisations Marketing Authorisations Regulation of Post Marketing Safety Monitoring medicines Licensing of manufacturers and wholesale dealers Inspections Enforcement and Prosecution Overseeing Notified Bodies Regulation of medical Post Market Surveillance/inspection devices Enforcement and prosecution Adverse Event reports Blood Safety and Inspections quality ©