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.
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.
