EMA list of medicines under additional monitoring and final advice clinical trial advisory groups

European Medicines Agency publishes initial list of medicines under additional monitoring
Uit't persbericht: The European Medicines Agency has published today the initial list of medicines that are subject to additional monitoring. This represents an important deliverable of the new European pharmacovigilance legislation. These medicines will have to display an inverted back triangle in their package leaflet and in the information for healthcare professionals called the summary of product characteristics (SmPC), together with a short sentence explaining what the triangle means.

All medicines on the European Union (EU) market are carefully monitored. If a medicine is labelled with the inverted black triangle, it does not mean that it is unsafe; the purpose of the symbol is to actively encourage healthcare professionals and patients to report any suspected adverse reactions observed with the medicine, either because the medicine is new to the market or because there is a limitation to the data available on its safety. Lees verder.

European Medicines Agency publishes final advice from clinical trial advisory groups
Uit't persbericht: The European Medicines Agency (EMA) has published the final advice from the advisory groups that have been set up to inform the EMA in drafting its policy on proactive access to clinical-trial data.

The EMA has committed to the proactive publication of data from clinical trials supporting the authorisation of medicines once the marketing-authorisation process has ended, which the EMA does not consider commercially confidential.

The release of data is ultimately about establishing trust and confidence in the system.The EMA is committed to transparency and openness of information to meet the legitimate public interests to enable scrutiny of the Agency’s recommendations on medicines. Lees verder.