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eCTD NEWS

RECENT NEWS

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eCTD Industry Update (18th September 2023)

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)...
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eCTD Industry Update (13th September 2023)

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...
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eCTD Industry Update (4th September 2023)

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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eCTD Industry Update (21st August 2023)

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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eCTD Industry Update (18th September 2023)

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...
Read More
etch weekly update image

eCTD Industry Update (13th September 2023)

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...
Read More
etch weekly update image

eCTD Industry Update (4th September 2023)

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)
Read More

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BLOGS

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Choosing an eCTD service provider

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...
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Which eCTD and electronic publishing services should I use?

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...
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How to fix common eCTD validation issues

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...
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Tips for efficiently preparing eCTD documents

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...
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Why regulatory writers need eCTD templates?

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,...
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Are eCTDs mandatory?

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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