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Public Health

Commission Expert Group on Safe and Timely Access to Medicines for Patients ("STAMP")

The STAMP expert group is set up to provide advice and expertise to the Commission services in relation to the implementation of the EU Pharmaceutical legislation, as well as programmes and policies in this field.

The STAMP will exchange views and information about the experience of Member States, examine national initiatives and identify ways to use more effectively the existing EU regulatory tools with the aim to further improve safe and timely access and availability of medicines for patients.

Repurposing of medicines

In June 2019, STAMP, with the European Medicines Agency (EMA) and stakeholders, developed a proposal for a framework to support not-for-profit organisations and academia in drug repurposing. The proposed framework will be tested through a pilot project launched by EMA and the Heads of Medicines Agencies on 28 October 2021.

The aim of the pilot is to support not-for-profit organisations and academia to gather or generate sufficient evidence on the use of an established medicine in a new indication to have this new use formally authorised by a regulatory authority.

This is a way of making affordable new treatment options available to patients. Further information is available in a question-and-answer document.

The pilot is open to not-for-profit stakeholders and academia (institutions and individuals) who have a particular interest in repurposing an authorised medicine for a new indication in an area of public health interest, have a scientific rationale for their repurposing programme and would like to seek scientific advice with a regulatory authority. They should apply to EMA or national authorities:

European Medicines Agency: Scientific advice and protocol assistance (see under ‘Scientific advice on medicine repurposing’)

Heads of Medicines Agencies

The pilot is one of the actions highlighted in the Pharmaceutical Strategy for Europe to inform the review of the pharmaceutical legislation. For more details of the strategy see: A pharmaceutical strategy for Europe.

Overview of the activities of the STAMP expert Group in 2015 – 2016.

Meetings

Additional information