On Friday 7 May, the European Commission opened a public feedback on its draft revision of the legislation on medicines for rare diseases (141/2000) and on medicines for children (1901/2006): this revision was one of the major promises made by the Commission in its pharmaceutical strategy and will be its main initiative regarding unmet therapeutic needs (see EUROPE 12710/9).
The aim of the draft revision, expected in the first quarter of 2022, will be to encourage research and development of medicines for children and people with rare diseases, “in better alignment with patient needs”, the Commission explains.
The initiative should also aim to improve the availability and timely access to these medicines. It will also establish more efficient procedures for the assessment and authorisation of medicines for children and people with rare disease.
The public feedback will remain open until 30 July. To access: https://bit.ly/2Qe63oX (Original version in French by Agathe Cherki)