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US FDA Adverse Event Reporting System (FAERS) Electronic Submissions
Is the US Food & Drug Administration in final preparations for switching to E2B(R3)?
EMA Publishes New Timeline For DADI Project
Updated DADI Human Variations Form Timeline and revised go-live scope
US FDA Adopts ICH Clinical Trials Guideline with Exclusive Reference to E2B (R3) Standards
US Food & Drug Administration announced that they adopted the ICH E8(R1) guideline on general considerations for clinical studies.
CMDh Updates Guidelines to Implement Northern Ireland Protocol (Brexit relevant information)
Updated practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DC
US FDA announces that DTD version 3.3 will be made mandatory for eCTD submissions
US FDA announced the requirement for Electronic Common Technical Document (eCTD) Module 1 U.S. Regional DTD Version 3.3 starting from 01 March 2022.
Use of E2B(R3) Becomes Mandatory June 2022 - How to Prepare
In January 2020, the EMA’s management board announced that the use of E2B(R3) will become mandatory in production as of 30 June 2022.
EU Clinical Trials Regulation Now in Effect
The EMA released the new Clinical Trials Regulation, replacing the Clinical Trials Directive on 31 January 2022.
EMA Updates Technical Guidance for eCTD Submissions in the EU
The European Medicines Agency (EMA) has published version 5.0 of its Harmonized Technical Guidance for eCTD Submissions in the EU on 17 December 2021.…
MHRA updates Guidance for Centrally Authorized Products (CAPs) to UK Marketing Authorization (MAs)
The Medicines and Healthcare products Regulatory Agency (MHRA) has updated its Guidance for CAPs with further information on the submission process…
New EU Guidance on Data Submission for Investigational Medicines
On October 20th, 2021, the EMA released guidance on the submission of information on investigational medicinal products for human use in the xEVMPD.
Australia readies itself for eCTD only
Starting 1st November Australia’s TGA will begin the transition to eCTD format only for all prescription medicine. Find out which products will be…
China NMPA will be accepting eCTD submissions from 29th December 2021
eCTD submissions will be accepted by China NMPA as an optional submission format by end of 2021.
The FDA’s OPDP eCTD is now in effect - what does it mean for you?
Providing Regulatory Submissions in Electronic and Non-Electronic Format - Promotional Labeling and Advertising Materials for Human Prescription…
OMS to become mandatory for all submissions to EMA
From 1st of October 2021, applicants will have to to use the OMS to register with the EMA for medicinal products
The Mystery of the EU IG - Insider Perspective
Anjana Pindoria is part of EXTEDO’s product management team and a member of the EU Telematics group, after working 9 years for pharmaceutical…
Implementation of the new Veterinary Medicines Regulation
New Guidance on Handling of DCP/MRP
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.
中国药品监督管理局（CDA）开始要求使用eCTD标准
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。
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…
EMA Officially Endorses the New EudraVigilance System for Adverse Reactions
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…
Why we believe in IDMP and you should too
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…
Health Canada confirms mandatory use of eCTD format from 1st January 2018
From the beginning of next year, Health Canada will only accept submissions for certain regulatory procedures in the electronic common technical…
eRA 2017 - A first-timers impressions
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…
Overview of the New Requirements for Electronic Submission of Drug Master Files (DMFs)
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.…
ESubmissions in South America
South America is still taking its first tentative steps towards the standardization of submission dossier formats for registered medicinal products.…
The impact of mandatory reporting of non-serious cases in EudraVigilance
Updated pharmacovigilance legislation within the EU will bring about significant changes to the requirements surrounding reporting of suspected…
The Business & Pharmacovigilance Impact of E2B(R3)
The changes introduced within E2B(R3) are not solely technical, they have a significant impact on the overall pharmacovigilance processes. In this…
Introduction to E2B(R3)
Over the years, various legislation has defined the process of adverse event reporting, and most recently E2B(R3) introduces the latest iteration to…
A Roadmap for IDMP Implementation & Compliance
The idea is simple - to remain compliant, life sciences organizations need to demonstrate that they are in control of their business, processes and…
The Five ISO IDMP Standards Explained
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.
Introduction to ISO IDMP
This series of posts takes a closer look at the ISO IDMP standard and how best to implement it within your organization.