Post-marketing surveillance of medicines: the Black Triangle scheme

By Paul England

The European Medicines Agency (EMA) launched a new post-marketing surveillance system in the autumn called the ‘Black Triangle’ scheme. This follows a similar scheme in the UK, where the Commission on Human Medicines (CHM) and the Medicines and Healthcare products Regulatory Agency (MHRA) encourage practitioners and patients to report any adverse effects of medicines labelled with the inverted Black Triangle logo. However, this is the first time the Black Triangle logo has been introduced onto medicines marketed in EU countries. It is hoped that this scheme will prevent the reoccurrence of previous failures of additional monitoring of high-profile drugs including Vioxx (an osteoarthritic) and Avandia (an anti-diabetic), which both remained on the market for some time before safety problems were detected.

The clinical trial requirements for the introduction of medicines onto the current market are familiar:

  • Phase 0 or I: regarding pharmacodynamics, pharmacokinetics and safety of a new or novel drug
  • Phase II: regarding the efficacy of a drug, often determined by recruiting a small cohort of healthy patients
  • Phase III: often the therapeutic confirmatory phase carried out in excess of 1,500 subjects where subject inclusion and exclusion criteria are quite strict to match the subset

The number of subjects recruited into a clinical trial is usually small relative to the total patient population, and the testing period (usually six to 12 months) is often short compared with the relevant course of therapy…

Click on the link below to read the rest of the Taylor Wessing briefing. 

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