Regulatory Focus™ > News Articles > Black Symbols to Adorn Dozens of New Drugs Approved in EU Starting in September, EMA Says

Black Symbols to Adorn Dozens of New Drugs Approved in EU Starting in September, EMA Says

Posted 26 April 2013 | By Alexander Gaffney, RAC

The European Medicines Agency (EMA) announced this week that it has released its first-ever list of products that must be adorned with a new symbol first announced earlier this year that is meant to convey that the products have not yet been sufficiently assessed in a postmarketing setting.

Background

The regulation requiring the symbol was announced in March 2013, and is binding on and in all Member States of the EU.

The symbol itself is supposed to be proportional to the text it accompanies, with each side of the triangle no smaller than 5 mm in length, and is intended to allow patients and healthcare professionals to easily and quickly identify which products are subject to additional monitoring to allow them to report suspected adverse events.

The rule comes into effect on 1 September 2013, and will apply to all non-generic medicinal products authorized after 1 January 2013, including biological medicinal products. Also included are all products approved before 1 January 2013 that are subject to additional monitoring, which must have the symbols on their packaging by 31 December 2013. Extensions may be granted on a case-by-case basis as requested if the sponsor can show that the change would "unduly affect the appropriate and continued supply of the medicinal product."

Existing stock "produced, packaged and labeled" before 1 January 2014 can be marketed even without the black symbol "until stocks are exhausted," the regulation states.

The Initial List

EMA has just published the first list of all medicines that will be required to be adorned with the black symbol, which includes a veritable group of recently-approved medications, including Pfizer's Bosulif and Champix, Eli Lilly's Amyvid, GlaxoSmithKline's Belysta, Takeda's Edarbi, Bristol-Myers Squibb's Eliquis, uniQure's Glybera, Novartis's Gilenya, and Elan's Tysarbi, to name but a few.

EMA said it hopes that the triangle will promote greater adverse reporting for new medicines, whose clinical trials often are not able to identify all potential safety issues that will eventually affect a given product. By keeping a closer eye on potential events, EMA said it will be able to warn consumers about safety issues sooner than before.


EMA Notice on Black Triangle


Tags: EU

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