EMA Signal Detection Pilot and New MAs…

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 Hamard is a Pharmacist with more than 15 years of Global Pharmacovigilance Auditing experience and over 200 PV Audits performed since his company PVFocus was established in 2004.

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