The Signal Detection Pilot started on 22-Feb-2018 and concerned MAHs are
now required to monitor EudraVigilance data and inform Authorities of validated
signals detected in the database. Only those MAHs whose active substances are
included in the list of products involved in the pilot are subject to these new
requirements.
In March 2018, we published the response we received from the EMA to a
question we asked regarding the possible addition of New Active Substances to
the list. We were wondering whether the new requirements would apply to
companies who get a new substance approved while the pilot is ongoing but the
EMA confirmed that the list of substances involved in the pilot is fixed and
will not change (link to our March 2018 post here).
Anna Marques, EU QPPV at Eignapharma (link to their website here), was wondering
about another scenario: What if you get a new Marketing Authorisation for a
product that is already in the list, for instance if you register a new generic
product ?
That’s also an interesting question and I would like to thank Anna for accepting to share
the response she received from the EMA, which states that the new requirements
do not apply to products that became authorised after the start of the pilot.
Anna’s exchange with the EMA is available in a comment to our March 2018 post (link to our March 2018 post here).
In conclusion, only companies that were MAHs for products included in
the list at the beginning of the pilot are concerned by the new Signal
Detection requirements and this will not change during the pilot. I hope this helps !
Thierry is also Chief Editor of Safety Observer, a provider of Regulatory Intelligence services for Pharmacovigilance since 2005.
