News and Educations

PRAC News – February 2014


During its meeting in February 2014, the Pharmacovigilance and Risk Assessment Committee (PRAC) did not start any safety review of medicines, neither new recommendations were adopted and the Committee focused on the wide spectrum of its responsibilities encompassing all aspects of risk management regarding the use of medicines.

The PRAC activities precede to granting marketing authorisation of medicinal products, such as the risk management plan assessment of medicines that are being reviewed, as well as the activities following the granting of marketing authorisation, such as the PSUR based on which, after new data have been collected the benefits/risks ratio in the medicinal product life cycle are being re-assessed. The PRAC also reviews safety signals , which is the key public health role thus ensuring a fast discovery and evaluation of new or adulterated safety issues and also when needed in the interest of patient safety protection, introduction of variations in labelling or restrictions for use.

The summary of recommendations of safety signals is published two weeks upon the PRAC meeting.

The information on all topics discussed at the PRAC are available on the European Medicines Agency web pages, or here. The record of the discussions held at this meeting will be made publicly available after the next PRAC meeting in March.