原创力文档- 1、原创力文档（book118）网站文档一经付费（服务费），不意味着购买了该文档的版权，仅供个人/单位学习、研究之用，不得用于商业用途，未经授权，严禁复制、发行、汇编、翻译或者网络传播等，侵权必究。。
- 2、本站所有内容均由合作方或网友上传，本站不对文档的完整性、权威性及其观点立场正确性做任何保证或承诺！文档内容仅供研究参考，付费前请自行鉴别。如您付费，意味着您自己接受本站规则且自行承担风险，本站不退款、不进行额外附加服务；查看《如何避免下载的几个坑》。如果您已付费下载过本站文档，您可以点击 这里二次下载。
- 3、如文档侵犯商业秘密、侵犯著作权、侵犯人身权等，请点击“版权申诉”（推荐），也可以打举报电话：400-050-0827(电话支持时间：9:00-18:30)。
- 4、该文档为VIP文档，如果想要下载，成为VIP会员后，下载免费。
- 5、成为VIP后，下载本文档将扣除1次下载权益。下载后，不支持退款、换文档。如有疑问请联系我们。
- 6、成为VIP后，您将拥有八大权益，权益包括：VIP文档下载权益、阅读免打扰、文档格式转换、高级专利检索、专属身份标志、高级客服、多端互通、版权登记。
- 7、VIP文档为合作方或网友上传，每下载1次， 网站将根据用户上传文档的质量评分、类型等，对文档贡献者给予高额补贴、流量扶持。如果你也想贡献VIP文档。上传文档
查看更多
缩写Acronyms CCG - Co-ordinating Centre for GCP CPP - Certificate of Pharmaceutical Product CRO - Contract Research Organisation CT - Clinical Trial CTC - Clinical Trial Certificate CTERU - Clinical Trials Epidemiology Research Unit EC - Ethics Committee GCP - Good Clinical Practice HSA - Health Sciences Authority MAC - Medicines Advisory Committee MCRC - Medical Clinical Research Committee NCEs - New chemical entities 主要的政府机构Major Government Agencies 保健科学卫生局（HSA）The Health Sciences Authority (HSA) 2001年4月1日形成的新法令A new statutory board formed on 1 April 2001 卫生部门的5个研究部门综合制定的Established by the integration of 5 specialised departments under the Ministry of Health 药物评价中心Centre for Drug Evaluation 科学医学药物所Institute of Science and Forensic Medicine 国家医药管理局National Pharmaceutical Administration 产品规范部门Product Regulation Department 新加坡输血服务Singapore Blood Transfusion Service The Health Sciences Authority (HSA) 8个中心8 Centres: Centre for Pharmaceutical Administration (CPA) Centre for Drug Evaluation (CDE) Centre for Radiation Protection (CRP) Centre for Medical Device Regulation (CMDR) Centre for Transfusion Medicine (CTM) Centre for Forensic Medicine (CFM) Centre for Forensic Science (CFS) Centre for Analytical Science (CAS) Centre for Pharmaceutical Administration (CPA) 前期的市场产品评估和许可Pre-market product evaluation and licensing Licensing of manufacturers, importers, and wholesalers Evaluation and certification of clinical trials Assessment and certification of GMP Licensing of retail pharmacies Post-marketing activities Investigation and prosecution of illegal sale Licensing of retailers of tobacco products Centre for Pharmaceutical Administration (CPA) All clinical trials on medicinal products require a Clinical Trial Certificate (CTC) from CPA, HSA. The Medical Clinical Research Committee (MCRC) advises on the licensing of clinical drug trials. Organisation Chart of CPA Primary activities relating to control of Western medicines Processing applications for new product li
文档评论（0）