PSURs Archives | European Regulatory Affairs Specialists

Pharmacovigilance most of all

23rd April 2020

The European Medicines Agency (EMA) has recently published an overview of pharmacovigilance activities that outlines just how strong and reliable a system we have in the EU. The report was prepared by EMA in collaboration with the National Competent Authorities (NCA). The report includes quantitative data covering the period between 2015 and 2018 and shows that the European regulatory network for medicines is held accountable for the implementation of the pharmacovigilance legislation.

The measurement of impact is based on a strategy and action plan for measuring the impact of pharmacovigilance activities, adopted by EMA’s safety committee (PRAC) in 2017.

It shows that the EU pharmacovigilance system is strong and protects public health.

Some key outcomes 2015-2018

More than 500 new or updated risk management plans were assessed by the PRAC each year, ensuring the safety monitoring and risk minimisation is proportionate and planned. In addition, nearly 7,000 risk management plans were assessed by the Member States for nationally authorised medicines during the reporting period.
Enhanced EudraVigilance database of suspected side effects, resulting in improved reporting and greater analytical power;
Evaluation of nearly 9,000 potential signals (information about new or changing safety issues potentially caused by a medicine) by EMA’s signal management team over the period covered by the report, and a similar number of potential signals assessed by Member States;
Radical simplification and improvement of the way periodic safety update reports are handled, by establishing a common repository with a single portal for access;
Development of criteria to determine when a public hearing on issues of medicines’ safety would be of value, and the successful holding of the first such hearings, for valproate-containing medicines in 2017 and for quinolone and fluoroquinolone antibiotics in 2018;
Continued development of the ‘Article 57 database’, which now contains information on more than 800,000 medicinal products authorised through central, decentralised, mutual recognition and national procedures across the European Economic Area.

For more details on the report please refer to EMA web page where you can access the press release issued.

The pharmacovigilance legislation established now reinforces the need for and format of various reports, including:

Risk Management Plans (RMP);
Periodic Safety Update Reports (PSUR);
Post-Authorisation Safety and efficacy Studies (PASS);
Pharmacovigilance System Master Files (PSMF).

Should you require assistance with respect to setting up a pharmacovigilance system, or the preparation and submission of pharmacovigilance related data we encourage you to contact us.

Written by Alice D’Alton.

Launch of the new EudraVigilance System – National arrangements for Ireland and what this means for you

15th November 2017

With the launch of the improved EudraVigilance (EV) System, and the move to the simplified reporting of adverse reaction reports (ADRs) on 22^nd November 2017, Marketing Authorisation Holders and EV users in Ireland must familiarise themselves with the HPRA’s national arrangements that will be in place during the changeover period.

As of 4^th November the HPRA closed its reporting gateway and MAH’s must not submit ICSRs/SUSARs to HPRA from this time, as all submissions will be lost upon go-live date (22^nd November) in the system (EudraVigilance Go-Live Plan).

To facilitate EV users, there will be a 3-day ‘cutover legacy’ period from 22^nd – 24^th November when all ‘backlog’ ICSRs can be submitted to EudraVigilance with Compliance timelines adjusted to reflect the downtime during this period.

Any SUSARs sent to EVCTM from 4^th to 7^th November should be submitted to HPRA after 22^nd November along with the other cutover legacy SUSARs. Sponsors and investigators are also obliged to notify the HPRA within 3 days of any action needed to protect the health and safety of clinical trial subjects, in accordance with the HPRA Guide to clinical trial applications

New Simplified reporting of Adverse Reaction Reports

From 22^nd November all serious ICSRs that occur within or outside the EU will be reportable directly to EudraVigilance and no longer to individual National Competent Authorities (NCAs)/ Marketing Authorisation Holders (MAHs).

All non-serious cases occurring in the EU will also be reportable to EudraVigilance by NCAs and MAHs. These final reporting arrangements are further described in Revision 2 of Module VI of the Good Pharmacovigilance Practice guide.

All reporting shall be in line with the final reporting arrangements as described in Directive 2001/83/EC as amended. Therefore all serious and non-serious ICSRs that occur in Ireland will be reportable directly to EudraVigilance by the MAH and not to the HPRA.

A key aspect of the new EudraVigilance system is its compatibility with the E2B(R3) format. Stakeholders may submit and receive ICSRs and SUSARs in the E2B(R3) format from 22^nd November 2017 onwards, if their internal systems have been updated to meet this requirement.

For MAH EVWEB users any reports will automatically be generated in the E2B(R3) format and so it is recommended that these MAHs undergo training on EVWEB and the new ICH E2B(R3) format to gain familiarity with new functionalities and changes as there will be a new interface and improved functionalities.

We can help

Ivowen are fully equipped to advise and assist during this changeover period and beyond. Please see our Pharmacovigilance services page or contact us for more information.

Written by:

Edel Behan

EMA eSubmission Gateway – tips & tricks

28th August 2017

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/

Open Internet Explorer and log into EMA portal. Go to “Send document”.
If you see the “Click to send documents totalling more than 10 MB” then continue to send your submission as normal.
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.

Ivowen attends EudraVigilance Training Course on Reporting of ICSRs/SUSARs in the EEA – Suspected Adverse Reactions to Medicines

30th November 2016

What is EudraVigilance?

EudraVigilance (http://eudravigilance.ema.europa.eu) is a centralised European database of suspected adverse reactions to medicines that are authorised or being studied in clinical trials in the European Economic Area (EEA) and supports the safe and effective use of medicines (Figure 1 – EudraVigilance System Components). Adverse reactions (ADRs) can be reported during the development and following the marketing authorisation of medicinal products in the EEA. The European Medicines Agency (EMA) operates the system on behalf of the European Union (EU) medicines regulatory network.

ICSR, SUSAR and Safety Signals

Specifically, EudraVigilance is a system for managing and analysing information on suspected adverse reactions to medicines by facilitating electronic exchange of adverse event Individual Case Safety Reports (ICSRs) between EMA and all stakeholders including national competent authorities (NCAs), marketing authorisation holders (MAHs) and sponsors of clinical trials in the EEA. Within clinical trials such a case is referred to as a SUSAR (a Suspected Unexpected Serious Adverse Reaction). The reporting of ICSRs allows for the early detection and evaluation of possible safety signals leading to improved product information and benefit-risk balance for marketed medicines authorised in the EEA. A Safety Signal is defined as information on a new or known adverse event that is potentially caused by a medicine and that warrants further investigation. Signals are generated from several sources such as spontaneous reports, clinical studies and the scientific literature.

Taking into account the pharmacovigilance activities in the pre- and post-authorisation phase, EudraVigilance provides two reporting modules:

The EudraVigilance Post-Authorisation Module (EVPM)
The EudraVigilance Clinical Trial Module (EVCTM)

Figure 1. EudraVigilance System Components

Data Publishing, Review and PRAC Evaluation

EMA publishes data from EudraVigilance in the European database for suspected adverse drug reaction reports – http://www.adrreports.eu/. EMA, NCAs and MAHs are responsible for reviewing EudraVigilance data to detect safety signals. The Pharmacovigilance Risk Assessment Committee (PRAC) evaluates the safety signals detected in EudraVigilance and may recommend regulatory action as a result – http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000537.jsp&mid=WC0b01ac058058cb18.

What we can do for you:

Electronic reporting of suspected adverse reactions to medicines is mandatory for MAHs and sponsors for clinical trials. Ivowen can advise and assist you in the following areas of reporting to EudraVigilance along with updating product information for PRAC recommendations:

Describe the Registration process with EudraVigilance
Create, validate and send safety messages (initial, follow-up reports, nullification reports, literature reports, parent-child , study reports, reports with medical and drug history)
Create and send acknowledgments of received ICSR messages
Query, view, browse and download safety reports
Query, view and browse MedDRA through the EVWEB

Please contact us for further information.

Written by Laura Oakey.

PSUR repository updated

25th August 2015

On the 26th of January 2015, the EMA introduced the pilot phase on the use of the XML delivery file for submissions of PSURs via the eSubmission Gateway/Web Client.

This introduction,

1) Simplified package file names for PSURs and

2) Introduced the requirement of an XML delivery file.

The XML delivery file is created in the PSUR Repository user interface

The PSUR Repository user interface is basically broken down into 4 sections:

Section 1: Regulatory Activity

This is a simple drop down list and is currently only available for PSUR submissions and Supplementary information which is related to a PSUR submissions.

Section 2: Details of assessment procedure

This section requires you to enter the Procedure Number as per the EURD list, all other information (Submission deadline, DLP, Active name, Rapporteur name and Rapporteur country) will prepopulate based on this Procedure Number. Carefully check if all information is correct, if prepopulated information is wrong contact the EMA.

Section 3: Product Selection

Select your Submission Format (eCTD or NeeS)
Enter the product name(s) in the section products to which the submission relates for all your products to which the submission relates. This is a drop down menu based on the Art 57 database. Therefore you must first ensure that all your product information entered in the Art 57 database is up to date and correct.
Select your products, enter your procedure number (where relevant) and the sequence number of your submission.

Section 4 Routing information

Enter EMA routing ID (e.g. ESUBPROD) and your Routing ID (e.g. ESUBPTESTPROD123)
The XML delivery file will always be called xml, this should not be renamed/edited
Save the XML delivery file inside the PSUR submission folder (zipped).
Your PSUR folder should have a meaningful file name and examples of these can be found in Annex 3.
Your Submission file can be send in the normal manner via the eSubmission Gateway/Web Client.

From September 2015, it will be mandatory to use the XML delivery file for all PSUR submission to the EMA via the eSubmission/Web Client.

Please contact us if you require any further information or help with this process.

Written by Fiona Downey.

Pharmacovigilance most of all

Launch of the new EudraVigilance System – National arrangements for Ireland and what this means for you

EMA eSubmission Gateway – tips & tricks

Current State of Play

Contact us

“Click to send documents totalling more than 10 MB”

Ivowen attends EudraVigilance Training Course on Reporting of ICSRs/SUSARs in the EEA – Suspected Adverse Reactions to Medicines

PSUR repository updated

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