Black Triangle Scheme

This section provides information about reporting suspected adverse drug reactions for healthcare professionals. Information for patients is available in the 'Patient reporting of suspected adverse drug reactions' section (please see 'Related information on the right of this page').

What are Black Triangle drugs (▼)?
When medicines come onto the market, we have relatively limited information about their safety from clinical trials in the UK. These trials generally involve only small numbers of eligible patients who take the medicine for a relatively short period of time. Therefore, patients in clinical trials may not be fully representative of those who will use the medicine when it is marketed.

Only when large numbers of patients have taken a medicine are rare or long-term adverse effects identified. Therefore, effective surveillance after marketing is essential for the identification of rare adverse effects, and to ensure that appropriate action is taken.

New medicines are intensively monitored to ensure that any new safety hazards are identified promptly. The Commission on Human Medicines (CHM) and the MHRA encourages the reporting of all suspected reactions to newer drugs and vaccines, which are denoted by an inverted Black Triangle symbol (▼). This symbol appears next to the name of a relevant product:

• the British National Formulary (BNF)
• in the British National Formulary for Children (BNFC)
• in the Nurse Prescribers' Formulary (NPF)
• in Monthly Index of Medical Specialities (MIMS)
• in the Association of the British Pharmaceutical Industry (ABPI) Medicines Compendium
• on advertising material
• in Drug Safety Update

Why is it a Black Triangle product (▼)?
A Black Triangle is assigned to a product if the drug is an active substance which has been newly licensed for use in the UK. However, a product containing previously licensed active substances may also be monitored and assigned Black Triangle status if it meets one or more of the following criteria:

• it contains a new combination of active substances
• administration of the drug via a new route of administration or drug delivery system
• a significant new indication which may alter the established risk/benefit profile of that drug
• an established medicine which is to be used in a new patient population.

All similar biological medicines (biosimilars) have a Black Triangle symbol because every new biological product has been developed to be similar to an existing biological product, however may not have an identical structure therefore requires intensive monitoring for safety and efficacy.

Why do we monitor Black Triangle drugs (▼)?
We wish to receive all reports of suspected adverse reactions associated with Black Triangle products, in order to:

• confirm risk/benefit profiles established during the pre-marketing phase
• increase our understanding of the safety profiles of new medicines
• ensure that we identify previously unrecognised side effects as quickly as possible.

Clinical trials generally involve small numbers of patients who take a medicine for a relatively short period of time, and there are strict conditions for the inclusion of patients in such trials. This means that the patients in whom the medicines are tested during the trials may not be fully representative of the patients who will use the medicine when it is marketed.

In addition, it is not until large numbers of patients have taken a drug that we can detect side effects which are rare or which appear after long-term use. Close monitoring of new medicines once they are being more widely used in the general population enables us to identify such side effects and take appropriate action.

As well as requesting reports on all Black Triangle products, the MHRA encourages the reporting of all serious suspected reactions to established drugs and vaccines, even if the effect is well known.

Why is there an asterisk next to the Black Triangle (▼*)?
For example, the Black Triangle symbol has been reinstated for Cozaar▼* (losartan), specifically for the new indication of heart failure. Furthermore, Cancidas▼* (caspofungin) has had a Black Triangle reinstated after it was approved for use in children.

Some established products may have the Black Triangle symbol reinstated - for instance if the product has been approved for use in a significantly new indication or in a new population. These products are denoted by an asterisk next to the Black Triangle (▼*).


What if the drug has been reinstated in the Black Triangle Scheme (▼)?
Please email the MHRA’s Black Triangle team (blacktriangle@mhra.gsi.gov.uk) if your company holds the marketing authorisation for a drug that has the Black Triangle reinstated due to the product being approved for use in a significantly new indication or in a new population.

Why apply for (▼*)?
Applying for ▼* could be very beneficial for the marketing authorisation holder (MAH) and the MHRA, as well as prescribers.

• Marketing authorisation holders will have reduced administrative burden as they would only report for the newly licensed indication or a population for a well established drug.
• We, the MHRA, will gain clearer understanding about the safety of the drug for a newly licensed indication. The assessment of the risk/benefit profile will be faster and more efficient as we would only obtain reports of adverse events from newly licensed indication or a population.
• Prescribers will obtain effective information concerning the reinstatement of the Black Triangle for a well established drug.

How long is a drug under the Black Triangle Scheme (▼)?
The MHRA assesses the Black Triangle status of a product usually two years after marketing. However, there is no standard time for a product to retain Black Triangle status. The symbol is not removed until the safety of the drug is well established.

The CHM and the MHRA continue to monitor intensively all products with a Black Triangle symbol (▼). Healthcare professionals are asked to report all suspected adverse drug reactions to these products through the Yellow Card Scheme.

The symbol ▼* highlights the importance of reporting suspected adverse reactions that are related to the reason for reinstating the Black Triangle to the drug (eg, use in a new indication or new patient population). Such reporting helps us to:

• confirm the risk/benefit profile that was established during clinical development
• increase our understanding of the safety profile of new products
• ensure that we identify previously unrecognised side effects as quickly as possible.

What are the reporting requirements for Black Triangle drugs (▼)?
For health professionals and patients
The MHRA strongly encourages the reporting of all suspected reactions to Black Triangle medicines.

For industry
The Medicines and Healthcare products Regulatory Agency follows the guidance as per Volume 9A of The Rules Governing Medicinal Products in the European Union – Guidelines on Pharmacovigilance for Medicinal Products for Human Use (external link).

Marketing authorisation holders (MAHs) have a legal reporting requirement to reports adverse drug reactions and explanation of these are laid out in Chapter 4.3.1, the Annexes 6.1.1, 6.1.2 and 6.1.3.

The Black Triangle reporting requirements are shown in Annex 6.1.2 of Volume 9A.

The only additional requirement for Black Triangle products reporting for MAHs is that the MHRA requests that all serious reports from within the UK and EU be reported.

The Black Triangle (▼) on Summaries of Product Characteristics (SPCs)
The Black Triangle is not a part of the common technical document (CTD) hence it is not required that a Black Triangle be displayed in the SPC that is submitted to the MHRA as part of the CTD.

For clarification, the Black Triangle symbol is only displayed against products in:

• in the British National Formulary (BNF)
• in the British National Formulary for Children (BNFC)
• in the Nurse Prescribers' Formulary (NPF)
• in Monthly Index of Medical Specialities (MIMS)
• in the Association of the British Pharmaceutical Industry (ABPI) Medicines Compendium
• on advertising material
• in Drug Safety Update.

The Black Triangle (▼) on advertising material
Specifications for the Black Triangle symbol can be found in the Code of Practice for the Pharmaceutical Industry as contained in the The Association of the British Pharmaceutical Industry (ABPI) Data Sheet Compendium. In clause 4.2 it is stated that:

“The symbol should always be black and its size should normally be not less than 5 mm per side but with a smaller size of 3 mm per side for A5 size advertisements and a larger size of 7.5 mm per side for A3 size advertisements:

• the symbol should appear once and be located adjacent to the most prominent display of the name of the product
• no written explanation of the symbol is necessary.”

For specific Black Triangle enquiries please contact us at: blacktriangle@mhra.gsi.gov.uk  

Current drugs under intensive surveillance (Black Triangle List)
The intensive surveillance list gives details of all marketed Black Triangle drugs and is updated monthly.

Drugs under intensive surveillance (Black Triangle List): Trade names - August 2010 (123Kb)
Drugs under intensive surveillance (Black Triangle List): Generic names - August 2010 (97Kb)