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MHRA Publishes Guidance Note If No Brexit Deal

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Thursday January 3, 2019 issued “Further guidance note on the regulation of medicines, medical devices and clinical trials if there’s no Brexit deal” to document how the MHRA proposes to regulate medicines if there is “no deal” for “Brexit”.

“If there’s no deal, the UK’s participation in the EMRN (EU medicines regulatory network) would cease and the MHRA would take on the functions currently undertaken by the EU for human medicines on the UK market.”

For more details click the link below to see the full MHRA Guidance Document.


FDA Delays eCTD Requirements for DMF and BPF by 1 year

Yesterday (Friday April 7, 2017) the FDA announced in an updated guidance that it has delayed until May 5, 2018 the requirement for DMF and BPF submissions to be submitted in eCTD format. Other submission types, NDA, ANDA and BLA, must still meet the 5 May 2017 deadline for submission in eCTD format. For those who have already converted their DMF submissions to eCTD format, you are now 1 year ahead!


Revised FDA Guidance:

4/7/2017 Providing Regulatory Submissions in Electronic Format – Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (ucm333969.pdf)

RAPS article:


DIA “EDM and ERS/eCTD 2014” Conference September 22-24, 2014

The DIA “EDM and ERS/eCTD 2014” conference is being held at the Omni Shoreham Hotel, 2500 Calvert Street NW, Washington, DC 20008, on September 22-24, 2014 (tutorials the day before). Click here for more information including the agenda and hotel information.

While you’re at the show let’s connect! Write me on the Contact Us form and click “Let’s Meet” and in the comments section let me know what’s a good time to meet and how we can help you. Or call us at 206-734-0500 (Seattle time!).

And while you’re there, stop by the booths of our Partners:

  • EXTEDO to review the new features of the latest release of eCTDmanager and learn of other eRegulatory Solutions.
  • RegDocs365 and find out more about hosted Regulatory solutions; plus I’m helping them out in the booth so stop by and say “hi”.

And be sure to mention that 515 Consulting sent you!

515 Consulting Group participates in test of the FDA ESG for Health Canada submissions

515 Consulting Group was one of only 16 companies that participated in the Health Canada electronic submission testing. The final testing, Phase IIb, using the production FDA ESG occurred on October 3 and 4.

As noted in the HC email to participants today:

“… HC took some valuable feedback away from the experience of testing … Your feedback has been extremely helpful and will be put towards official HC guidance on the ESG and managing future pilot projects. … We are aiming to have the first real submission received through the CESG late October/early November.”

515 Consulting is looking forward to its first electronic submissions through the CESG. If you anticipate having a HC eCTD submission, please contact us.

Please pass this post on to others you think would benefit from knowing about the Canadian ESG for eCTDs.

FDA releases new eCTD Module 1 documents

As mentioned in my last post, at the DIA Annual Meeting in Boston at the end of June, the FDA announced that the implementation of the long awaited new eCTD Module 1 would be delayed until June 2014. The FDA has now released 4 guidance documents for vendors and industry to prepare for the new Module 1:

There are many advantages for migrating eCTDs to the new Module 1 format. 515 Consulting Group uses EXTEDO’s eCTDmanager to prepare and publish eCTD submissions to the FDA and other Authorities around the world and since we will want to migrate our client’s eCTDs when the time comes, we asked Karteek Sandadi, Professional Services Manager for EXTEDO in North America when eCTDmanager will support the new M1 functionality. We were pleased to learn that EXTEDO plans to support the new FDA M1 functionality in eCTDmanager in the Q1 2014 timeframe. We look forward to trying it out.

FDA Delays New eCTD Module 1

At last week’s DIA Annual Meeting in Boston the FDA announced that the long awaited new eCTD Module 1 would be delayed until June 2014. In addition, the FDA is changing the DTD. So, if you have been waiting for the FDA to start accepting the new M1 so you could add your documents into those 4 new sections at the end of M1, you’re going to have to wait about another year longer.

FDA Posts eCTD Validation Specifications v2.2

Yes that’s right, 2.2! As you may know, FDA started using Validation Criteria 2.1 on 30 April. In the 2.1 spec all the new/changed items had an “Effective Date” of “Pending”. All 2.2 does is change all the “Pending” to “4/30/2013”. No items were added/deleted/changed. Click here to download the new 2.2 version specifications from the FDA website.

And don’t forget to validate your own eCTDs with v 2.1/2.2 specs now!

DIA EDM/eSubs only 2.5 weeks away

The DIA EDM/eSubs conference, or as the DIA calls it, “EDM and ERS/eCTD 2012” , being held at the Baltimore Hilton Hotel from October 9-11, 2012 (Tutorials: October 8), is only 2 weeks away. Find out more at http://www.diahome.org/en/Flagship-Meetings/12003-EDM.aspx . And while you’re there, stop by the Sage Submissions booth (#301) and find out how Sage Templates can make the preparation of your Regulatory documents easier and more accurate and the new features of v2.

Sage Templates releases 510(k) templates for FDA CDRH presubmissions and submissions and cross-mapped to STED

Sage Templates now include templates for 510(k) with cross mapping to GHTF Summary Technical Documentation (STED). Templates are designed to conform to granularity and PDF file format requirements of FDA CDRH Electronic Copy mandate contained in FDASIA and MDUFA III. Please email info@sagesubmissions.com if you would like additional information or a sample copy.

Source: http://www.linkedin.com/e/-c0g6q7-h6f31dcl-4c/ava/154166112/2738309/eml-anet_dig-b_nd-pst_ttle-cn/?hs=false&tok=3ampKxBk7rm5o1