EMA launches ‘black triangle’ post-marketing scheme
pharmafile | April 28, 2013 | News story | Sales and Marketing | EMA, Post-marketing surveillance, black triangle, pharmacovigilance
The European Medicines Agency has unveiled its new ‘black triangle’ post-marketing surveillance system, and the list of drugs that will face extra monitoring.
The move is a central plank of the new European pharmacovigilance legislation, aimed at detecting problems and side-effects which cause harm to patients.
Europe’s post-marketing surveillance was judged to have failed in numerous cases in recent years – most notably Vioxx, Avandia and Mediator, which all stayed on the market for years because serious safety problems were not picked up.
The EU is adopting a long-standing UK system, the ‘black triangle’ scheme, whereby novel medicines and those judged to be at greater risk of side-effects must display warnings alongside a black triangle in their leaflet and in the summary of product characteristics (SmPC).
It is hoped the move will encourage healthcare professionals and patients to report any suspected adverse reactions they observe.
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).
Other medicines can also be placed under additional monitoring, based on a recommendation from the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC).
A medicine can be included on this list when it is first approved, or at any time during its lifecycle. It remains under additional monitoring for five years or until the PRAC decides to remove it from the list, usually because studies have further established the safety profile of the product concerned. The complete additional-monitoring list will be reviewed every month by the PRAC and published on the EMA website.
Implementation plan
The black triangles will start appearing in the package leaflet and SmPC on the medicines from autumn 2013.
Marketing-authorisation holders of affected medicines will need to update the product information to include the new black symbol and explanatory text, using the latest version of the product-information templates.
- For new medicines, the Agency encourages marketing-authorisation applicants to start using the new product-information template if an opinion from the Committee for Medicinal Products for Human Use (CHMP) is expected in May 2013. Any new medicine on the list authorised after 1 September 2013 will include the black symbol in the package leaflet and the summary of product characteristics when it is placed on the EU market.
- For medicines that are already authorised, marketing-authorisation holders are encouraged to use the new template at the next regulatory procedure affecting the product information. If there are no such procedures, companies should submit a type-IAIN variation no later than 31 December 2013.
An implementation plan outlining the exact regulatory process and timeline companies need to follow to comply with these new requirements is available from the EMA.
The full list of medicines to be monitored can be found on the EMA’s website at
www.ema.europa.eu/docs/en_GB/document_library/Other/2013/04/WC500142453.pdf
Andrew McConaghie
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