The initiative on Medicines for children & rare diseases – updated rules has been updated on the European Commission’s ‘Have your say‘ portal, and a public consultation is open.
This initiative explores  several options to address the shortcomings identified in the evaluation of the Regulations on medicines for children and rare diseases, in view of a revision of the existing legislation.

Contribute to this consultation: it is open until 30 July 2021.

EU rules to incentivise the development of medicines for children and for people with rare diseases have been in place for nearly 20 years. This revision addresses shortcomings identified in a recent evaluation, aiming to ensure that:

  • products addressing the specific needs of children and patients with rare diseases are developed
  • these groups have timely access to medicines
  • there are efficient assessment & authorisation procedures.