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 is, what it should contain and what best practices to follow for an eCTD baseline submission to MHRA. 

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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 applications and the way they work in order to remain compliant. 

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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 submitted to the FDA in eCTD format.

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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 (Common European Single Submission Portal).

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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 2018. But what do you have to take into consideration before submitting to the FDA?

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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 formats NeeS and eCTD.

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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 4.0.

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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 through the key concepts in eCTD 4.0. 

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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 presentation at an industry conference or an internal meeting and heard about some of the deliberations and revisions going on behind the scenes. In short, life science organizations, authorities and vendors alike have been waiting for things to unfold for quite some time.

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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 London, the EMA will be required to transfer their headquarters to another EU member state upon the UK's exit from the union. In preparation for this, they recently issued a press release defining their planned actions.

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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 science organizations who have not yet began preparing for the new regulatory requirements are advised to act quickly to meet the upcoming deadline.

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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 EudraVigilance database system for collecting and monitoring suspected adverse reactions.

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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 Brexit processes. This means that no EU Implementation Guidelines (EU IGs) will be published in 2018, and there will be no need to start submitting product data in the new format in 2019.

It may have caused a disturbance in the industry, but whether you were skeptical about the original implementation deadlines or not, one thing remains - IDMP will still happen, with or without Brexit!

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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 document (eCTD) format. As of that date, Health Canada says that sponsors must use eCTD format for all new drug submissions (NDS) and abbreviated new drug submissions (ANDS), as well as supplements to both submission types. On 24th of April 2017, Health Canada officially confirmed the deadline for eCTD submissions - to read the official announcement from Health Canada, click here.

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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 we learned at this year's eRA event. This year was my first time at eRA. From the latest IDMP updates to the best tapas dish of the meal, and everything in between, there were great discussions all around. For the conversation alone, I must say that it was a couple of days well invested. With 40 keynote and breakout sessions taking place over the course of the two days, there was also plenty to see and learn.

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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. This upcoming regulation is expected to promote efficiency of the DMF review process, but are companies ready to comply? Learn more about the new regulation and how to navigate the transition in order to remain compliant.

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South America is still taking its first tentative steps towards the standardization of submission dossier formats for registered medicinal products. Most countries within the region have their own local format and some allow information to be submitted electronically on their local portals.

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Updated pharmacovigilance legislation within the EU will bring about significant changes to the requirements surrounding reporting of suspected adverse reactions and non-serious cases. To support these changes, the European Medicines Agency (EMA) is launching a new EudraVigilance system with enhanced functionality. In November 2017 the reporting of non-serious cases will become mandatory.

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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 post we look at some of regulatory changes specifically called out by the EMA.

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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 the ICH E2B technical specification.

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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 data. Whatever the regulation, the higher the degree of internal data governance, the lower the cost and effort associated with compliance.

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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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