The European Medicines Agency has published a list of drugs that are subject to additional monitoring, and as such will have to display an inverted black triangle on their packaging. The EMA say the purpose of the symbol is to encourage healthcare professionals and patients to report any adverse reactions. The list includes drugs that are either new to the market, or those that have limited data available on their safety.
The list of over 100 drugs includes several vaccines, including Novartis' men B vaccine Bexsero, Medimmune's intranasal Fluenz, Baxter's Vepacel and three GSK vaccines – Nimenrix, Pandemrix and the newly approved Influsplit Tetra.
The criteria for medicines that are subject to additional monitoring are:
- medicines authorised after 1 January 2011 that contain a new active substance;
- biological medicines for which there is limited post-marketing experience;
- medicines with a conditional approval or approved under exceptional circumstances;
- medicines for which the marketing-authorisation holder is required to carry out a post-authorisation safety study (PASS).
Drugs on the list that are authorised after 1 September 2013 must include the black symbol from the outset, while currently approved drugs must display the inverted black triangle by the end of the year. These new regulations come against a background of changes to European pharmacovigilance legislation.
Do you think this is a good initiative? Or just more unnecessary red tape?
You can join our discussion on LinkedIn or leave a comment below, I'd love to hear what you think.
You can join our discussion on LinkedIn or leave a comment below, I'd love to hear what you think. You might be interested in attending the World Vaccine Congress Europe 2013, 16-17 October, Lille, France.
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