Wednesday, June 24, 2015

Early dialogue to support development of medicines for children

EMA’s early interaction meetings encourage consideration of paediatric needs in the early phases of medicine development.

The European Medicines Agency (EMA) has launched an initiative that offers free-of-charge early paediatric interaction meetings with medicines developers to stimulate early dialogue on the development of their medicines for use in children. A one-year pilot phase is starting today.
The new initiative aims to encourage discussions on the paediatric needs that could be addressed with a specific medicine well before the submission of a paediatric investigation plan (PIP).

Medicines developers that wish to participate in the pilot phase are invited to provide information on their medicine using a specific form and send it

In the European Union, pharmaceutical companies are obliged to develop all new medicines also for use in children. The paediatric development is detailed in a PIP that needs to be agreed with EMA’s Paediatric Committee (PDCO).
While assessing PIPs submitted by medicines developers, EMA identified a number of issues which often delay the paediatric development and consequently children’s access to the medicine. Often, development programmes for adults and children are not sufficiently integrated and the possibility to extrapolate the results of studies in adults to children is not always explored to its full extent.
Early discussion between developers, EMA and its PDCO on the overall paediatric development strategy is expected to help medicines developers optimise the development plan for their medicine and ultimately speed up access to the medicine for children.

About the initiative

Following receipt of a request for an early paediatric interaction meeting, an EMA paediatric coordinator and a PDCO representative will be appointed as well as additional participants from other EMA departments or national competent authorities as required. A date for a teleconference with the applicant will then be arranged.
EMA can only consider a limited number of applications during the pilot phase and the Agency will give priority to medicines that address major public health needs.
The procedure will be reviewed at the end of the pilot and may be modified based on the experience gained.

For further information on the early paediatric interaction meetings, see the last question within the section 'Applying for a PIP, waiver or deferral' on Paediatric investigation plans: questions and answers.