eCTD NEWS
RECENT NEWS
EMA Clinical Trials Information System (CTIS): online modular training programme (updated) FDA Update on In-Person Face-to-Face Formal Meetings with FDA
EMA Changing the name or address of a sponsor (updated) News and press releases: Mandatory use of CTIS from 31 January 2023 for all new clinical trial applications Regulatory and procedural guideline: European Medicines Agency certificates of medicinal...
CMDh UPDATE - Chapter 2: Procedure for automatic validation of Mutual Recognition Procedures for Variations - Clean Version / Tracked Version UPDATE - Chapter 3: CMDh BPG for the processing of Type IA Minor Variations (Notifications) in the Mutual...
EMA European Medicines Agency post-authorisation procedural advice for users of the Centralised Procedure Clean Version / Tracked Version (updated) European Medicines Agency Pre-authorisation guidance - Clean Version / Tracked Version (updated) Regulatory and procedural guideline:...
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EMA Clinical Trials Information System (CTIS): online modular training programme (updated) FDA Update on In-Person Face-to-Face Formal Meetings with FDA
EMA Changing the name or address of a sponsor (updated) News and press releases: Mandatory use of CTIS from 31 January 2023 for all new clinical trial applications Regulatory and procedural guideline: European Medicines Agency certificates of medicinal products - instructions on how...
CMDh UPDATE - Chapter 2: Procedure for automatic validation of Mutual Recognition Procedures for Variations - Clean Version / Tracked Version UPDATE - Chapter 3: CMDh BPG for the processing of Type IA Minor Variations (Notifications) in the Mutual Recognition Procedure - Clean Version...
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BLOGS
The use of electronic Common Technical Documents or eCTDs has revolutionised regulatory procedure. Providing a vital link between organisations within the pharmaceutical sector and regulatory health authorities like the FDA and EMA, eCTD submissions offer a convenient and efficient way...
The benefits of eCTD are many. As the mandatory format requirement for several regulatory health authorities – including those in Europe, the US, Canada, Switzerland, Australia, GCC, South Africa, Japan, Thailand and Jordan – eCTDs offer the efficiency, formatting and...
As this revision history proves, the FDA updates its specifications for eCTD validation criteria continually, a fact that makes it extremely difficult to keep up with the changes and so easy to miss an update. Whilst eCTD submission specialists like...
The FDA is just one health authority that has made the submission of ANDAs, NDAs, BLAs, DMFs and Commercial INDs in eCTD format mandatory. With paper and non-eCTD submissions no longer accepted across many application types, getting to grips with...
When preparing your eCTD submission, every little helps. An eCTD (electronic Common Technical Document) submission is after all an extremely complex process, with the tender of regulatory information such as applications, reports and supplements, and the associated documentation and cross-links...
eCTDs are no new thing. This would-be global standard was launched in 2003 within the regulatory health industry to ensure both technical and regulatory requirements were met with the effectiveness and efficiency that technology allowed. Since then, the use of...
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