EMA Launches Pilot for Pediatric Drug Reviews

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 06-19-2015 17:12


The European Medicines Agency (EMA) has launched an initiative that offers free-of-charge early pediatric interaction meetings with medicines developers to stimulate early dialogue on the development of their medicines for use in children. A one-year pilot phase has begun.

The new initiative aims to encourage discussions on the pediatric needs that could be addressed with a specific medicine well before the submission of a pediatric investigation plan (PIP). In the European Union, pharmaceutical companies are obliged to develop all new medicines also for use in children. The pediatric development is detailed in a PIP that needs to be agreed with the EMA’s Pediatric Committee (PDCO).

While assessing PIPs submitted by medicines developers, the EMA identified a number of issues which often delay the pediatric development and consequently children’s access to the medicine. It noted that development programs 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. The EMA said that early discussion between developers, the EMA and its PDCO on the overall pediatric development strategy is expected to help medicines developers optimize the development plan for their medicine and ultimately speed up access to the medicine for children.

The EMA outlined the procedure. Following receipt of a request for an early pediatric interaction meeting, an EMA pediatric 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 said that i 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 said the EMA.

Source: European Medicines Agency


Thank you for reading DCAT Value Chain Insights (VCI), an information resource from the
Drug, Chemical & Associated Technologies Association (DCAT). 

Learn more and sign up to receive a complimentary subscription