What is a Black Triangle in Pharmacovigilance?

A black triangle is a regulatory symbol (an inverted, black triangle) used in pharmacovigilance to denote medicines that are under intensive monitoring due to their recent approval or significant updates in safety information. It is typically placed on medicine packaging or labels (i.e., package leaflet or summary of product characteristics) and indicates that the medicine is subject to additional monitoring by regulatory authorities. This is usually because there is little or significantly less information available on the medicine compared to other medicines since it is new or data regarding the long-term use of the product is limited. However, it does not mean that the medicine is unsafe to use. This monitoring is crucial for identifying and assessing new safety concerns that may arise once the medicine is on the market.

What are the factors that determine a medicine’s black triangle symbol?

• The medicine contains a new active substance that was authorized in the European Union (EU) after the 1st of January 2011;
• The medicine is a biological product (i.e., vaccine or plasma (blood) derived) and was authorized in the EU after the 1st of January 2011;
• The medicine has obtained “conditional approval” or is approved under “exceptional circumstances”;
• The pharmaceutical organization that markets the medicine must provide more data/information on the long-term use of the medicine, OR on a rare side effect observed in clinical trials;
• The medicine is authorized with specific obligations on the recording of suspected adverse drug reactions.

EMA shares its updated list of medicines that are subject to additional morning on its website and publishes list on the site of the national competent authorities (NCAs) of the EU Member States. The Pharmacovigilance Risk Assessment Committee (PRAC) reviews this list every month.

What are the regulatory challenges associated with a black triangle medicine?

Medicines that are marked with the black triangle symbol are indeed subject to heightened regulatory scrutiny. Some of the regulatory challenges associated with these medicines revolve around ensuring effective monitoring, risk communication, and risk management:

Data Collection & Analysis: One challenge is the comprehensive collection and analysis of real-world data for black triangle medicines. This requires robust pharmacovigilance systems capable of capturing and evaluating safety information from diverse sources.

Timely Reporting: Encouraging timely reporting of adverse events and side effects related to black triangle medicines is another challenge. Healthcare professionals and patients need to be aware of the importance of reporting, and mechanisms must be in place to facilitate easy and efficient reporting processes.

Regulatory Strategies Updates: Keeping prescribing information and labelling up-to-date with the latest safety information poses a challenge. Regulatory authorities must review and incorporate new safety findings into the medicines labelling promptly, ensuring that healthcare professionals and patients have access to accurate and relevant safety information.

Risk Communication: Effectively communicating the risks associated with black triangle medicines while maintaining public trust in their benefits is crucial. Balancing transparency about potential risks with the need to avoid unnecessary alarm requires clear and target communication strategies.