As everyone knows, the New EudraVigilance System was implemented on 22-Nov-2017 and brings enhanced Signal Detection and Data Analysis tools to support safety monitoring directly by MAHs.
As described in the latest revision of GVP Module IX on Signal Management, Marketing Authorisation Holders (MAHs) have a requirement to continuously monitor EudraVigilance data and inform EMA and National Competent Authorities of validated signals detected in the database.
Transitional arrangements have however been agreed in order to streamline the implementation of this new process and during a pilot period of one year starting on 22-Feb-2018, only those MAHs whose active substances are included in the list of products involved in the pilot will be subject to the new requirements.
The list of substances involved in the pilot (1) was first published by the EMA on 27-Oct-2017 and was updated as necessary (1). As initially communicated by the EMA, the list of substances involved in the pilot was first based on the list of medicines under additional monitoring in the EU (2), i.e. the list of Black Triangle Products, which is revised on a monthly basis by the EMA (2). And this made us wonder…
Can products be added to the list during the Pilot ?
I have worked for a Start-Up company recently which is awaiting its first Marketing Authorisation in Europe. As the product is a new active substance, it will obviously be added to the list of Black Triangle Products and so we were wondering whether the product will also be added to the list of substances involved in the Signal Detection pilot.
I tried to find the response to this question in the information available on the EMA website but I could not find what I was looking for. And so I sent my question to the EMA.
EMA Says No !
I was pleased to receive a conclusive response within a day, and the EMA confirmed that the list of substances involved in the pilot is fixed and will not change over the duration of the pilot.
I don’t know if many people also wondered about this but I hope this is helpful. I believe the EMA has since removed any reference to the list of Black Triangle Products for the avoidance of doubt.
Here is a copy of the exchange I had with the EMA:
“I wonder if you could clarify this for me : I know that the list of products for the Signal Detection pilot is based on the list of products under additional monitoring. If a new product is approved over the next year, it will go to the list of Black Triangle products but what about the Signal Detection pilot ? Will the list of products for the pilot be revised on an on-going basis or is fixed for the year to come ? Many thanks in advance.”
“Re: EMA request reference ASK-39482
Dear Mr Hamard,
Thank you for your query. We confirm that the pilot list is fixed i.e. it will not be affected by changes to the additional monitoring list (additions or deletions).
European Medicines Agency”