The EMEA launched such a consultation in order to prepare the implementation of the proposed EU paediatric medicines regulation.
EFA and IPCRG stressed the role of patients organisations in providing expertise and experience. They also highlighted some of the specific characteristics of paediatric pharmacovigilance with regard to asthma.
It is worth noting that they support an extensive prospective monitoring that should be fully independent and all data shall be made available.
The EMEA consultation process echoes timely with the publication of the Council of health Ministers position on the paediatric medicines directive. It is believed that the European Parliament should process shortly with the adoption of its opinion in second reading.
