2019 – What a year

Ivowen attended the Medicines for Europe conference in January (Regulatory and Pharmacovigilance), the annual EuDRAcon conference in May, exhibited at TOPRA in October and joined our clients from around the world at CPhI in November.

We all saw Brexit come and go, Twice !! We wait to see what lies in store for the next deadline in January 2020.

The FMD came into effect across Europe in February in most member states.

Bulgaria joined CESP, eCTD became mandatory for all human procedures, lots of new guidance was published (to keep us all on our toes) and Nitrosamines in medicinal products moved to the top of everyone’s agenda.

With the festive season now upon us and 2020 on the horizon, Ivowen are setting our sights on the year ahead.

We will be attending the Medicines for Europe conference in January 2020 (Regulatory and Pharmacovigilance) and we encourage you to contact us before mid-January with any specific questions you might like us to ‘ask the regulators’. This is a great opportunity to ask those difficult questions that you just could not get a straight answer to in 2019, on the ever present grey areas of Regulatory procedures.

To help you to plan ahead here are some helpful updates, in brief, as full articles will be posted in 2020:

Falsified Medicines Directive – Where we are now:

  • Implemented on 9th Feb 2019 in all MS except Greece, Italy and Belgium
  • The European Commission has produced a video to explain more about the safety features.
  • The HPRA have extended the use and learn period, initially to Sep 2019 and extended it again to end on a phased basis starting from 31st January 2020.
  • The MHRA is also taking a pragmatic, flexible approach to how they enforce the new legal requirements.

Nitrosamines

 

Ivowen are here to assist you in 2020 and will continue to provide the top quality service you have come to expect from us.

For more information on Ivowen’s services and how we can help you, contact us.

Written by Alice D’Alton.

Company Announcement – Majella Ryan FTOPRA

Majella Ryan FTOPRA

Ivowen are pleased to announce that Fellowship of The Organisation for Professionals in Regulatory Affairs (FTOPRA) has been conferred on Majella Ryan.  According to TOPRA:

The award of a Fellowship is intended to recognise a contribution in which the individual has used his/her professional knowledge and experience to influence, guide or develop the profession in a proactive way.
While clearly the individual’s regulatory experience and current senior position achieved are important, what is also looked for is a consistent record of activities or influences extending beyond the confines of the individual’s day-to-day activities.”

Majella Ryan has been in the regulatory affairs business for over 20 years and in this time has worked in both small and large multi-national companies, setting up Ivowen in 2002. Since then, Majella was involved in the set-up of TOPRA in Ireland, acting as the inaugural Chair in 2001/2011, as well as speaking at various conferences and providing extensive regulatory training to companies around the world.  In addition, Majella is actively engaged in the publication and explanation of regulatory and guidance updates via Ivowen’s website, and via Ivowen’s EU network, EuDRAcon.  As part of Ivowen’s daily work, Majella is involved in the high level regulatory strategy and support of complex projects and products like biosimilars, paediatric investigation plans and clinical trials, eCTD implementation, regulatory pathways to approval, Brexit planning, and much more.

For more information on Ivowen’s services and how we can help you, contact us.

 

 

 

eCTD is coming…

All good (and bad) things, must come to an end.  The NeeS (Non-eCTD electronic submissions) submission format, will no longer be accepted for any Marketing Authorisation applications (MAAs) or submissions in MRP or DCP from 1st January 2018. Centralised Procedure (CP) submissions have been mandatory in eCTD since 2010.  All new MAAs submitted using either the Decentralised Procedure (DCP) or the Mutual Recognition Procedure (MRP), have had to be in eCTD format since the middle of 2015.  As of 1st January 2018, all MRP submissions must be submitted in eCTD.  Therefore, if your application/product is not in eCTD format and you need to submit an MRP variation, you have to transition to eCTD for the next submission.

What is the timetable?

Starting from 1st January 2018 it is mandatory for all CP, DCP and MRP submissions to be in eCTD format.  For national procedures (NP) the deadline is currently set at 1st July 2018 for new MAAs.

Following quickly behind these requirements, all submissions in CP, DCP, MRP and NP will have to be in eCTD from January 2019.  At this stage, the exact date is not confirmed, but you need to be ready.

We can help…

Ivowen can create a baseline dossier for any submission based on currently approved information. Currently, baselines are not mandatory but some Member States are requesting them.  In addition, it is best practise to get your dossier into a baseline for all future submissions.

Ivowen can transition your application to eCTD at the next regulatory activity (variation, renewal, Article 61.3, etc.).

Ivowen can manage the eCTD lifecycle for you in-house and provide you with fully valid, submission-ready sequences.

Contact us for more information or for help with building your eCTD now.

EMA eSubmission Gateway – tips & tricks

Current State of Play

As many of you know, the EMA eSubmission Gateway/Web Client has been mandatory for all submissions for human medicinal products made through the Centralised Procedure since March 2014 and for veterinary products since January 2017.  In addition, all PSUSA/PBRER submissions are also made through this EMA eSubmission Gateway, and have been mandatory since June 2016.

Unfortunately, as many of you also know, there are some glitches and issues with this portal.  Below are the workarounds for some of these glitches.

 

Contact us

Please feel free to contact us if you need any help submitting through the EMA eSubmission Gateway/Web Client

 

“Click to send documents totalling more than 10 MB”

To send any submission through the portal and get an acknowledgement (“ACK”) for this submission, you have to use the “Click to send documents totalling more than 10 MB” option.  When you first log in or register for the EMA eSubmission Gateway, and go to the “SEND DOCUMENT” page, this option is not available.  This is down to Java settings and security.  The way around this is to set your Java security settings and exceptions as follows:

 

 

At the moment, you may find that the “Click to send documents totalling more than 10 MB” option is still not available, even when your security settings and exception list are correct.  The EMA Service Desk has assured me that they are working on this issue, but in the meantime you can follow the instructions below to work around this issue/

 

  1. Open Internet Explorer and log into EMA portal. Go to “Send document”.
  2. If you see the “Click to send documents totalling more than 10 MB” then continue to send your submission as normal.
  3. If you don’t see the “Click to send documents…” link, like this example, then follow the instructions below:

 

3.1       In the top right hand corner is a Settings button that looks like a machine wheel

3.2       Click on this Settings button and then click “F12 Developer Tools”:

 

3.3       If you see that the Document Mode is “11 (default)” like the screenshot below:

3.4       Change this to “10” and the “Click to send documents…” will appear:

3.5       You need to leave the F12 Developer Tools window with these settings OPEN until you have completed your submission.  The EMA Gateway Service desk is working on a fix for this problem, but this is the workaround for now.

New EU MA Applications will require eCTD Submissions by Q3 2015

Marketing Authorisation Applications for human use submitted using the Decentralised Procedure (DCP) will need to be provided electronically as eCTD by Q3 2015. Submission in eCTD for Mutual Recognition Procedures (MRP) will also be required by the start of 2017, and finally National Procedures by the start of 2018. eCTD is already required for Centralised Procedures.

The EMA also announced at the end of 2014 that Veterinary Drugs must be filed electronically starting in 2016 for CP/DCP, and all submissions by 2017 by VNeeS (Veterinary Non-eCTD Electronic Submissions).

Plans are also underway to replace the Microsoft Word-formatted application form with the eAF (Electronic Application Form) and the deadline will be Q1 2016. Further detailed guidance can be found under the following links:

European Medicines Regulatory Network eSubmission Roadmap

eSubmission Roadmap flow chart

Ivowen are fully eCTD-ready and compliant. Please contact us for more information and for support of your electronic applications.

Written by Laura Oakey
Laura Oakey