Signal Detection with EudraVigilance: A brief overview of changes to come

This post provides a short overview of the upcoming changes in relation to Signal Detection in Europe and the resulting new obligations for Marketing Authorisation Holders.

EMA issues revised GVP Module IX on Signal Management (12-Oct-2017)

The EMA has now released the final version of GVP Module IX on Signal Management (Rev. 1), which includes guidance for the continuous monitoring of EudraVigilance data by Marketing Authorisation Holders (MAHs).

It specifies that EudraVigilance data should be reviewed with a frequency proportionate to the identified risk, at least every 6 months. Module IX also describes the procedural options available to MAHs in the event they identify validated signals.

Methodological aspects of signal detection are now addressed separately in a new Addendum I, which introduces the concept of Designated Medical Events (DMEs). The list of DMEs contains 62 MedDRA Preferred Terms corresponding to serious medical concepts often causally associated with drugs across multiple classes.

EMA provides information on Signal Detection Pilot (27-Oct-2017)

As described in GVP Module IX, MAHs have a requirement to continuously monitor EudraVigilance data and inform the EMA and EU National Competent Authorities of validated signals detected in the database. This will become possible with the implementation of the new EudraVigilance system on 22-Nov-2017.

The EMA has defined transitional arrangements to streamline the implementation of this new process. During a pilot period of one year, only MAHs whose active substances are included in the list of medicines under additional monitoring will be subject to the new requirements.

This will apply from 22-Feb-2018, allowing 3 months for MAHs to become familiar with the new EudraVigilance system and adapt their processes. Other MAHs will have access to EudraVigilance data but the new obligations will not apply to them until the pilot is completed and the EMA defines the next phase of implementation.

Explore the topic further: Free Webinar !

Essjay Solutions Ltd will hold a Free Webinar on Signal Detection and EudraVigilance, which will provide an overview of these changes and offer some advice on how to manage them. This webinar will take place on 21-Nov-2017 at 11:00 AM GMT.

→  Link to EMA GVP Page

→  Link to EMA Signal Management Page (includes DME List)

→  Link to Essjay Solutions Webinar Registration Page

Thierry Hamard is a Pharmacist with more than 12 years of Global Pharmacovigilance Auditing experience and over 200 PV Audits performed since his company PV Focus was established in 2004.

Thierry is also Chief Editor of Safety Observer, a provider of Regulatory Intelligence services for Pharmacovigilance since 2005.