http://esubmission.ema.europa.eu/eumodule1/EU%20M1%20eCTD%20Spec%20v3.0.3-HHMG-20171108.pdf 该指南规定了向EU提交的eCTD模块1中可接收的文件类型、信封信息(eu-envelope)、文件夹结构以及命名规则 Harmonised Technical Guidance for eCTD Submissions in the EU v4.0 – April 2016 http://esubmission....
http://esubmission.ema.europa.eu/eumodule1/EU%20M1%20eCTD%20Spec%20v3.0.3-HHMG-20171108.pdf 该指南规定了向EU提交的eCTD模块1中可接收的文件类型、信封信息(eu-envelope)、文件夹结构以及命名规则 Harmonised Technical Guidance for eCTD Submissions in the EU v4.0 – April 20...
欧盟在欧洲地区应用了该eCTD规范,并加入欧洲模块1使其完整。 除了继续发展和维护电子递交标准外,为了适当地从EMA和各个国家主管部门的角度实施eCTD,有许多先决条件。这些措施包括开发必要的业务流程来接收和处理电子递交(特别是eCTD);制定政策,特别是关于电子归档的政策;以及制定和实施适当的技术基础设施和系统措施。 EMA...
Annex 11, computer guidelines for the EU's Good Manufacturing Practices. Good Laboratory Practices. Good Manufacturing Practices 2. PFSB 040122, the Japanese guideline. International Standards Organization (ISO) 9001. Pharmaceutical Inspection Convention Scheme (PIC/S)Good Practices Guidance for Inspectors...
Annex 11, computer guidelines for the EU's Good Manufacturing Practices. Good Laboratory Practices. Good Manufacturing Practices 2. PFSB 040122, the Japanese guideline. International Standards Organization (ISO) 9001. Pharmaceutical Inspection Convention Scheme (PIC/S)Good Practices Guidance for Inspectors...
“I have been using EXTEDO’s submission publishing and validation solution since the inception of eCTD, and EXTEDO has consistently provided impeccable guidance throughout the many changes in this field over the years." Ines Copers, Senior Regulatory Affairs Officer at THERABEL Pharma SA Schedule ...
1.http://esubmission.ema.europa.eu/ectd/ 2.http://www.fda.gov.downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM333969.pdf 3.http://www.fda.gov/cder/regulatory/ersr/default.htm 4.http://www.fda.gov/cder/guidance/index.htm#electronic_submissions ...
Suitability(CEPs)PA/PH/CEP(09)108,1R7.HarmonisedTechnicalGuidanceforeCTDSubmissionsintheEU 2 扫盲篇 名称：ThecertificateofSuitabilitytotheMonographsofEuropeanPharmacopia(欧洲药典合用性证书），简称COS或CEP证书CEP证书旳作用：证明生产厂家所申报旳产品符合欧洲药典旳原则要求，生产符合EGMP和ICHQ7旳要求合用范围...
欧盟eCTD模块1规范 2017.11 英文.pdf,EU Module 1 eCTD Specification Version 3.0.3 November 2017 Document Control Change Record Version Date Author(s) Comments 0.1 July, 2001 Stan van Belkum Draft 0.2 September, 2001 Stan van Belkum Draft 0.3 October, 2001
108,1R7.HarmonisedTechnicalGuidanceforeCTDSubmissionsintheEU 2 扫盲篇名称：ThecertificateofSuitabilitytotheMonographsofEuropeanPharmacopia(欧洲药典适用性证书），简称COS或CEP证书CEP证书的作用：证明生产厂家所申报的产品符合欧洲药典的标准要求，生产符合EGMP和ICHQ7的要求适用范围：仅限于欧洲药典收载的物质（原料药和...