State of Paediatric Medicines in the EU - 10 years of the EU Paediatric Regulation


In October 2017 the Commission presented to the European Parliament and the Council a comprehensive report on progress made in children's medicines 10 years after the Paediatric Regulation came into force.

From the summary of the report:

"...  the Regulation works best in areas where the needs of adult and paediatric patients overlap. Especially, in diseases that are rare and/or unique to children and which in many cases are equally supported through the orphan legislation, major therapeutic advances often failed to materialise yet. Why this is the case and why the orphan reward is in some instances not able to drive paediatric development in a similar way than adult orphan development requires further scrutiny.

(...)This report marks not the end, but an essential intermediate step in the debate on a joint vision about the future parameters for paediatric and orphan medicines. The further evaluation supporting this process aims at providing results by 2019 so to allow the next Commission to take informed decision about possible policy options. It will also allow the forthcoming results of the SPC evaluation for the future of the Paediatric Regulation to be taken into account.

In the meantime, the Commission is committed to a positive agenda of concrete actions in order to streamline the current application and implementation together with EMA22 wherever needed. This includes:
- providing additional transparency of new products authorised with paediatric indications;
- analysing the experience with use of deferrals and consider changes in practice to ensure speedier completion of PIPs;
- revisiting processes and expectations in the context of handling of applications for PIPs and if necessary adapt the corresponding Commission guideline;
- exploring opportunities to discuss paediatric needs in an open and transparent dialogue involving all relevant stakeholders like academia, health care providers, patients/care givers, paediatric clinical trial networks, industry and regulators;
- delivering regular updates about development and trends of the paediatric medicines landscape in the EU; and
- fostering international cooperation and harmonisation."

You can read the entire report at the homepage of the European Commission:



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