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EU launches black triangle drug monitoring scheme

New pharmacovigilance symbol will be used by all drugs needing additional monitoring

EMA black triangle symbolAll drugs under additional monitoring in the EU now have to contain an inverted black triangle symbol as outlined in updated pharmacovigilance standards.

The European Medicines Agency (EMA) announced earlier this year its intentions to introduce the scheme, which makes use of the symbol already in use in the UK, to strengthen drug safety measures across the whole of the EU.

It is part of wider pharmacovigilance changes put in place by the EMA, including the creation of a Pharmacovigilance Risk Assessment Committee (PRAC) and new powers for the EMA to ask for more post-marketing safety and efficacy studies.

The deadline for companies to introduce the triangle symbol on relevant products has now passed, with the EMA publishing a video and factsheet to explain to members of the public and healthcare professionals what the symbol represents.

Medicines containing the symbol will also need to carry a warning that states the product is "subject to additional monitoring".

Both the symbol and the warning will appear on product information, including at the top of the printed package leaflet.

The additional monitoring status does not apply to every drug, and will only affect certain medicines under close scrutiny by the EMA after approval.

This includes any medicine containing a new active substance authorised in the EU after January 1, 2011, or if the product is s biological medicine derived from plasma authorised after January 1, 2011.

Drugs granted conditional approval or under circumstance where the company is required to carry out additional studies on long-term effects are also affected.

The EMA explained the introduction was not a comment on the safety of the drug, but an “invitation” to report any issues with it.

It said: “If a medicine is labelled with the inverted black triangle, it does not mean that it is unsafe; the purpose of the symbol is to actively encourage healthcare professionals and patients to report any suspected adverse reactions observed with the medicine, either because the medicine is new to the market or because there is a limitation to the data available on its safety.”

The video (see above or on YouTube) to accompany the launch of the symbol includes comments from Dr June Raine, director of vigilance and risk management of medicines.

She said: “The black triangle is a simple way to tell that this medicine is being monitored particularly closely. It tells you that regulatory authorities are keeping an extra close eye on the safety of the medicine in real world, real life use.”

Article by
Thomas Meek

2nd October 2013

From: Regulatory

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