On 22-May-2017, EMA announced the go-ahead for their new EudraVigilance system for collection and monitoring of suspected adverse reactions.
This was a much-anticipated and awaited announcement following the recent completion of an independent audit of the system. As per the announcement of the EMA Management Board, following the independent audit and favorable recommendations from EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), the board confirmed that the updated EudraVigilance database has achieved full functionality and meets the functional specifications.
What are the Benefits?
There have been multiple discussions and updates on the new database for quite some time. Proposed Module VI details many of these and some are combined with E2B (R3) changes. The updated system will support better safety monitoring of medicines and a more efficient reporting process for stakeholders.
Below are some of the expected benefits:
- Enhanced search and more efficient data analysis capabilities
- Reduced duplication of effort, including sending ICSRs to Member States as marketing authorisation holders will no longer have to provide these reports to national competent authorities
- Streamlined submission process
- Enhanced collaboration with WHO database (in practice the Uppsala Monitoring Centre (UMC)
- Increased system capacity and performance to support large volumes of users and reports (including non-serious adverse reactions originating from the EEA)
- Increased transparency and broader access to reports of suspected adverse reactions by healthcare professionals and the general public via the adrreports.eu portal (the public interface of the EudraVigilance database)
- Better detection of new or changing safety issues, enabling rapid action to protect public health
What does this mean?
It means that the users of the system, i.e. national competent authorities, marketing authorisation holders and sponsors of clinical trials will need to ensure that their processes and local/global IT infrastructure are compatible with the new system and the agreed format as described under the revised change management plan which was released on 12-Aug-2016.
Further, in accordance with Article 2(3) of Directive 2010/84/EU, the Member States shall ensure that the obligation on the part of the marketing authorisation holder to submit information on suspected adverse reactions electronically to the EudraVigilance database applies as from six months after the functionalities of the database have been established and have been announced by the Agency, which means its use will be mandatory effective 22-Nov-2017.
Importantly, users can take a trial of the new functions of the EudraVigilance system and the internationally agreed format for ICSRs in a test environment, as of 26 June 2017.
There will be no change in reporting by patients and health providers to national competent authorities based on local spontaneous reporting systems, and reporting of suspected unexpected serious adverse reactions (SUSARs) during clinical trials will remain unchanged until the application of the new Clinical Trial Regulation (Major change) in 2018.
In short, this means that MAH’s need to make the necessary changes to their:
- Safety processes and procedures e.g. SOP, WI, Guidance documents, Safety agreements (SDEAs), Communication plan etc.
- Safety database
To bring these changes it’s important that:
- Teams are trained per the training offered by EMA, specifically including:
o Use of the new ICH E2B(R3) format
o EVDAS (EudraVigilance Data Analysis System)
o GVP Modules VI (revision 2)
o GVP Modules IX (revision 1)
o EudraVigilance Access Policy
- The necessary technology changes are implemented:
o Configure, where applicable, the local Gateway to support ICH E2B(R3) messages. (N.B. it is not necessary to replace the software)
o Ad interim, install a backwards/forwards conversion tool if the ICH E2B(R3) format cannot be processed yet locally
o Upgrade and move to an ICSR ICH E2B(R3) compliant system
As expected, following the Q2 completion of the audit and its recommendations, the much-anticipated implementation of the new EudraVigilance database is now announced and MAHs will have six months to prepare and be ready to implement by 22-Nov-2017. This also means that the Module VI revisions will come into effect very soon.
Preparation by all MAHs is key to ensure readiness (please refer to the webinar Sciformix conducted on 18-May-2017 titled, “An Industry Perspective on the Future Changes in Pharmacovigilance and Safety Assessment for IND Reporting”) and will require deployment of experienced resources to effectively test and implement the required changes, either using skilled internal staff or working with a service provider such as Sciformix.
- Consulting services: Understand the impact, identify gaps and strategize a solution
- Implementation services: Provide program management, resources and systems to implement and test your solution. We can use your database or ours.
- Ongoing services: ICSR processing and database maintenance support
By strategizing an approach now and employing resources, you can make your processes and system ready by November’s deadline.