There are currently many ongoing activities and discussions relating to Brexit and its potential implications across many different sectors.

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中国药品监督管理局(CDA)宣布,eCTD将成为中国境内电子提交材料的强制性标准。尚未开始为新的监管要求做准备的生命科学组织收到建议,其需要迅速采取行动,以满足即将来临的最后期限。

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The MHRA is introducing baseline submissions to assist the conversion from NeeS to eCTD. In this blog post we talk about what a baseline submission...

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As eCTD is becoming mandatory in more and more countries, it is at this point your Regulatory Operations team will need to transform their...

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With the FDA eCTD mandate for INDs and DMFs upon us, now all original applications and lifecycle submissions for human drugs and biologics must be...

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In this article, we will talk about EMA eSubmission gateway, CESP (Common European Submission Platform) and the future of both platforms; CESSP...

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 In below sections I will discuss some portable document format (PDF) specifications that you should also consider while publishing your submissions.

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We are upon uncertain times within the Regulatory world. The FDA has already started moving toward making eCTD mandatory for all submissions by May of...

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The end of 2018 will mostly mark the end of the practice of submitting dossiers for medicinal products marketed for humans in the two electronic...

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The Dutch bid won the tender through draw. Amsterdam defeated Milan and fourteen other entries.

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On October 4th the FDA released its version of the ICH M4 Granularity guidance, covering its thinking on granularity and keyword usage in eCTD 3.2 and...

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In this, the final post the eCTD 4.0 blog post series, we shed light on the expected eCTD 4.0 implementation plans and timelines.

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eCTD 4.0 has a variety of different new terminology. To make sure you can tell the difference between your CoU’s and UUID’s, this blog post will walk...

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In recent years, a lot has happened surrounding the development and evolution of the eCTD standard. You have probably already sat through an eCTD 4.0...

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The European Medicines Agency (EMA) recently released a business continuity plan dealing with the potential implications of Brexit. Currently based in...

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As of 2018, the Chinese Food & Drug Administration (CFDA) has announced that eCTD will become mandatory for electronic submissions within China. Life...

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On May 22, 2017 the European Medicines Agency’s (EMA) management board endorsed the start of the official countdown for the launch of the improved...

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The EMA recently announced that they will be delaying the roll-out of the new ISO IDMP standard within Europe until after the completion of the formal...

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From the beginning of next year, Health Canada will only accept submissions for certain regulatory procedures in the electronic common technical...

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With eRA 2017 behind us and the craziness of the last few months of back-to-back organization now over, it's time to take a step back and look at what...

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Come May 5, 2018, all Drug Master File (DMF) submissions will need to be filed electronically with FDA in an eCTD format, or they will be rejected....

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South America is still taking its first tentative steps towards the standardization of submission dossier formats for registered medicinal products....

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Updated pharmacovigilance legislation within the EU will bring about significant changes to the requirements surrounding reporting of suspected...

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The changes introduced within E2B(R3) are not solely technical, they have a significant impact on the overall pharmacovigilance processes. In this...

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Over the years, various legislation has defined the process of adverse event reporting, and most recently E2B(R3) introduces the latest iteration to...

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The idea is simple - to remain compliant, life sciences organizations need to demonstrate that they are in control of their business, processes and...

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In this post, the second in our series on IDMP, we take a closer look at the ISO standards that make up the new regulation.

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This series of posts takes a closer look at the ISO IDMP standard and how best to implement it within your organization.  

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