Therapeutic Goods Administration (Australia) to transition all regulatory submissions to eCTD-only, starting in 2021
MHRA Publishes New Guidance for Converting Centrally Authorized Products to UK Marketing Authorizations
UK’s Medicines and Healthcare products Regulatory Agency (MHRA) publishes new guidance on how to convert an existing Centrally Authorized Product…
EU IDMP Implementation Guide Version 1 Released
The European Medicines Agency (EMA) has recently published Version 1 of the EU IDMP Implementation Guide that aims to inform stakeholders about the…
The EMA announces that E2B(R3) will become mandatory from 30 June 2022
In January 2020, the EMA’s management board announced that the use of E2B(R3) will become mandatory as of 30 June 2022.
3 Vital Cloud Migration Considerations
This blog has been formulated to help guide you on your transition to the cloud and to assist you in finding the ideal cloud provider for your…
Benefits of the Cloud for Life Science Companies
In this blog post, we talk about the benefits of the cloud and how they apply to organizations within the life sciences industry.
The EAEU Electronic Submission Format
The Board of the Eurasian Economic Union has published decisions on the electronic submission of drug applications. These include decisions 78 and 79…
5 Ways Cloud-based Computing is Changing Business
The cloud revolution is here, and businesses around the world are enjoying the many benefits that cloud-based computing offers.
EU Medical Device Regulation 2020 - What You Need to Know
On 26 May 2020, the new EU Medical Device Regulation and the EU In-vitro Diagnostics Devices Regulation will come into effect. This blog post will…
Pharmacovigilance in a No-Deal Brexit Scenario
In this blog post we highlight the most important changes to be wary of in the case of a no-deal Brexit, according to the UK government.
Mandatory Use of eCTD For New DMF Submissions in Canada
From 01 January 2020, Health Canada will only accept new DMF applications submitted in eCTD format to enable a common submission intake process as…
Updated Version of the HMA eSubmission Roadmap (v2.2) Available
The final version of the HMA eSubmission roadmap has been updated on 21 June 2019.
Technical Validation: A Bottleneck in the Drug Registration Process?
In this article, we go through some of the general technical validation requirements and how to better understand them.
Brexit-related Topics Relevant to Medicinal Product Registration
There are currently many ongoing activities and discussions relating to Brexit and its potential implications across many different sectors.
MHRA to Introduce eCTD Baseline Submissions
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…
eCTD Publishing Standards: What you need to be aware of when moving from Paper/NeeS to eCTD
As eCTD is becoming mandatory in more and more countries, it is at this point your Regulatory Operations team will need to transform their…
eCTD Related Guidelines for US FDA and EU
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…
Submission Platforms in EU and Further Changes
In this article, we will talk about EMA eSubmission gateway, CESP (Common European Submission Platform) and the future of both platforms; CESSP…
PDF requirements for US FDA eCTD submissions
In below sections I will discuss some portable document format (PDF) specifications that you should also consider while publishing your submissions.
Submission of eCTD submissions to US FDA using the electronic gateway
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…
eSubmission Roadmap: The Decline of NeeS & the Roadmap to eCTD
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…
The European Medicines Agency (EMA) comes to Amsterdam
The Dutch bid won the tender through draw. Amsterdam defeated Milan and fourteen other entries.
eCTD 4.0: What's new in the Granularity Update?
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…
Implementation expectations of eCTD 4.0
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.
Key Concepts Behind eCTD 4.0 and their Impact on Product Submissions
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…
The Drivers and Benefits behind eCTD 4.0
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…
The EMA prepares itself for Brexit
The European Medicines Agency (EMA) recently released a business continuity plan dealing with the potential implications of Brexit. Currently based in…
The Chinese Food & Drug Administration moves to eCTD
As of 2019, the Chinese Food & Drug Administration (CFDA) has announced that eCTD will become mandatory for electronic submissions within China. Life…