Coordination and communication

Coordination and communication

Clinical trials

Notifications of clinical paediatric drug trials must saved in the Europe-wide EudraCT database. Similarly, trials carried out in third countries will be recorded in the database if they are contained in an agreed paediatric investigation plan approved by the Paediatric Committee.

The purpose of storing the data is to avoid duplicate trials within the EU. Part of the data contained in EudraCT forms and the findings will be made public at a later date to be announced by EMA.

Scientific advice and training

The European Medicines Agency (EMA) provides free scientific advice to support parties developing paediatric drugs. To ensure scientific consistency, EMA coordinates communications between the Paediatric Committee and the Committee for Medicinal Products for Human Use, the Committee for Orphan Medicinal Products, their working parties and any other scientific advisory groups. Additionally, EMA organizes meetings and training on paediatric medication. Information on the subject is posted on EMA's website.

Other international cooperation

International cooperation in the field of paediatric medicine is carried out with parties such as the US Food and Drug Administration (FDA) and the World Health Organization (WHO) which has launched a special project to promote the health of children.

Collection and utilization of existing data

Holders of marketing authorisation were obligated to submit all studies completed by the effective date of the Paediatric Regulation to the authorities for review if the product involved had been granted a marketing authorisation within the European Union. Work to evaluate the data submitted has been commenced in order to update the Summaries of Product Characteristics and Package Leaflets.

Holders of marketing authorisation are required to submit to the authorities all the studies pertaining to the use of authorised products in the paediatric population. The reports must be submitted to the authorities within six months of the completion of the study irrespective of whether it has been conducted in accordance with an agreed investigation plan for an authorised paediatric medicinal product or not.

The Member States are required to collect all the data available on all uses of the medicines in the paediatric populations and submit the information to the Agency in accordance with the instructions issued by the Paediatric Committee.