eCTD NEWS
RECENT NEWS
EMA 15/09/2023 Regulatory and procedural guideline: Compilation of Union procedures on inspections and exchange of information (updated) 15/09/2023 Newsletter: CTIS newsflash - 15 September 2023 14/09/2023 Regulatory and procedural guideline: Guidance on paediatric submissions (updated)...
EMA 08/09/2023 - Innovation in medicines (updated) 07/09/2023 - Template or form: Application form for European Medicines Agency certificates of medicinal products (updated) 05/09/2023 - Other: Frequently asked questions about parallel distribution (updated) 04/09/2023 - Frequently asked questions about parallel...
EMA 30/08/2023 How to prepare and review a summary of product characteristics (updated) 29/08/2023 Risk management plans (updated) Template: Declaration for the risk management plan (RMP) publication (updated)
EMA Newsletter: CTIS newsflash – 18 August 2023 Webinar on Regulatory Procedure Management for Product Lifecycle Management 1st roll-out on IRIS , Online, from 15/09/2023 to 15/09/2023
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EMA 15/09/2023 Regulatory and procedural guideline: Compilation of Union procedures on inspections and exchange of information (updated) 15/09/2023 Newsletter: CTIS newsflash - 15 September 2023 14/09/2023 Regulatory and procedural guideline: Guidance on paediatric submissions (updated) 14/09/2023 Webinar on Regulatory Procedure...
EMA 08/09/2023 - Innovation in medicines (updated) 07/09/2023 - Template or form: Application form for European Medicines Agency certificates of medicinal products (updated) 05/09/2023 - Other: Frequently asked questions about parallel distribution (updated) 04/09/2023 - Frequently asked questions about parallel distribution (updated) 04/09/2023 - Newsletter: CTIS newsflash...
EMA 30/08/2023 How to prepare and review a summary of product characteristics (updated) 29/08/2023 Risk management plans (updated) Template: Declaration for the risk management plan (RMP) publication (updated)
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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 to submit important...
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 quality that should always...
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 us are...
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 required,...
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 electronic common...
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