EudraVigilance Archives | European Regulatory Affairs Specialists

When will DADI application forms replace the current eAFs?

15th March 2022

The electronic application forms (eAFs) we are familiar with are in the process of being replaced later this year by a web based digital application form in a new eAF portal. The new eAF portal will look somewhat similar to the current IRIS portal.

This project, known as DADI (Digital Application Dataset Integration), is intended to be used for both CAP (Centrally Authorised Products) & NAP (Nationally Authorised Products) applications to make the future of form-filling and submission-handling more efficient at an EU level.

The Human medicinal product Variation application form will be the first to go live in DADI format. Every person involved in drafting an eAF will need to have an EMA account and user access. Companies who use consultants to prepare eAFs will need to make sure that they assign an EMA role to the consultant.

The next stages of DADI will cover the

Veterinary variation application form
Initial MAA form for Human and Veterinary products
Renewal form for Human and Veterinary products

How will it work?

The eAF will be filled in using the new eAF portal (via user interface).
The user will then finalise the eAF by generating a PDF rendition
This PDF version must still be included in the eCTD submission, as before.
It will not be possible to submit the form directly from the eAF portal

When will it happen?

As outlined in the EMA roadmap (link provided below) the two immediate key deliverables are as follows:

Key deliverables	Go-Live Time Lines
Key deliverables	Year	Quarter
Launch of Human variations web-form (parallel use of old and new variation forms as part of a Transition period)	2022	Q4 (October)
Use of variation web form only	2023	Q2 (April)

It is important for all industry stake-holders to keep up to date with the development of these new web-based forms by consulting the EMA website for updates at the various launch stages.

Where can I find information?

DADI Network Project Webinar – 18/01/2022 – Live broadcast is available here.
The updated DADI roadmap, including key milestones, is available here.
The updated version of the DADI Questions and Answers documents is available here.
The “Common factors in the Fast Healthcare Interoperability Resources (FHIR) data standard for Art57(2) and eAF”documents are available in the following link.

The project will be implemented in phases, through a set of projects known as SPOR (Substances, Products, Organisations and Referentials) data management services for Human products. The Union Product Database will be the source of data for Veterinary products.

What is SPOR?

SPOR datasets	Description of data types	Status
Substance Management Services (SMS)	Harmonised data and definitions to uniquely identify the ingredients and materials that constitute a medicinal product.	Under Development
Product Management Services (PMS)	Harmonised data and definitions to uniquely identify a medicinal product based on regulated information (e.g. marketing authorisation, packaging and medicinal information).	Under Development
Organisations Management Services (OMS)	Data comprising organisation name and location address, for organisations such as marketing authorisation holders, sponsors, regulatory authorities and manufacturers.	Operational
Referentials Management Services (RMS)	List of terms (controlled vocabularies) to describe attributes of products, e.g. lists of dosage forms, units of measurement and routes of administration.	Operational

Once the above PMS and SMS are in place, pharmaceutical companies should start preparing to replace their current data submission format in Article 57 Database from the eXtended EudraVigilance Product Report Message (XEVPRM) format to the new ISO IDMP compatible format (HL7 FHIR). Webinars and training will be provided by EMA in due course.

What do Marketing Authorisation Holders have to do at this stage?

Marketing authorisation holders need to check their data in SPOR (OMS) to ensure it is accurate and up to date. For CAPs the use of OMS data in the current eAF is already mandatory.
Marketing authorisation holders with authorised MA(s) need to check their data in Article 57 database (xEVMPD) to ensure it is accurate and up to date.

Should you need any support at this stage in getting ready for the new Application Form format please feel free to contact us & the Ivowen team will be here to help.

Written by Marian Winder

European Procedural Guidance during COVID-19 Pandemic

11th May 2020

In response to the significant impact the COVID-19 pandemic is having on European regulatory activity, the European Commission, the European Medicines Agency and the Heads of Medicines Agencies network (EC, EMA and HMA, respectively) have approved a number of measures to help the management of marketing authorisations for human medicinal products considered crucial during the pandemic period.

The objective of these measures agreed at European level is to promote regulatory flexibility, facilitate, simplify and accelerate the administrative procedures, as far as possible, in order to respond more efficiently to emerging needs during this period.

As a result, the EC recently published questions and answers on regulatory expectations for medicinal products for human use during the COVID-19 pandemic:

Questions and Answers on Regulatory Expectations for Medicinal Products for Human Use during the COVID-19 Pandemic

This Q & A document which provides guidance to marketing authorisation holders (MAH) includes the following topics:

renewal applications
sunset clause
an exceptional change management process (ECMP) for crucial medicines for use in COVID-19 patients
circumstances under which the validity GMP certificates and authorisations to manufacture/import can be extended
circumstances under which the validity GDP certificates and wholesale authorisations can be extended
adaptions to the work of a Qualified Person (QP)
the possibility of adapting quality requirements for medicines intended to be used for the treatment of COVID-19 patients
the impact on reporting into EudraVigilance of Individual Case Safety Reports (ICSRs)
flexibility in the labelling and packaging requirements to facilitate the movement of medicinal products within the EU

Further to the European Commission’s Q&A document, the CMDh has agreed additional questions and answers that provide practical information on how to specifically address and apply the provisions determined by the European Commission for MR/DC procedures:

Practical Guidance of the CMDh for facilitating the Handling of Processes during the COVID-19 Crisis

The CMDh document addresses issues such as the impact of COVID-19 on assessment timelines, how to use the ECMP procedure (which is only applicable for products that are crucial for the treatment of COVID-19 patients) and QP declarations based on a desktop audits. It also includes a useful annex that details Member States’ email addresses and links to relevant published guidance on MS websites.

Both documents will be updated and supplemented with additional information, as appropriate during the pandemic.

Everyone at Ivowen is working tirelessly to keep our clients applications on track. We are liaising with the National Competent Authorities all the time to ensure we avoid delays and get the best results possible in these unprecedented times.

If you need any assistance in this regard please don’t hesitate to contact us.

Written by Claire Brown.

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

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.

When will DADI application forms replace the current eAFs?

European Procedural Guidance during COVID-19 Pandemic

Pharmacovigilance most of all

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

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

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