Ref. Ares(2014)4226469 - 16/12/2014
Ref. Ares(2015)4890387 - 06/11/2015
EUROPEAN COMMISSION
HEALTH AND CONSUMERS DIRECTORATE-GENERAL
Health systems and products
Medicinal products – authorisations, European Medicines Agency
STAMP 1/001
DRAFT AGENDA
1st Meeting of the Commission Expert Group on
Safe and Timely Access to Medicines for Patients (STAMP)
27 January 2015 (10:00 – 18:00)
Centre A. Borschette, Room AB-0C, Rue Froissart 36, BE-1040
Brussels, Belgium
1. Opening and adoption of the agenda
2. Scope and operation of the STAMP
3. Member States proposals for areas to be considered by the STAMP
4. Exchange of experiences from national routes (other than clinical trials) for
making available medicines to patients before authorisation: early access
schemes, compassionate use etc.
Member States to present on a volunteer basis
5. EMA’s pilot project on Adaptive Licensing:
a. Short presentation of the aims, principles and timelines of the pilot project
b. Update on stage I of the project: the criteria for the selection of projects
and information on selected cases
c. Update on next steps of (stage II: in-depth discussion on selected cases)
6. Regulatory tools for early access:
a. Results from the Escher project ‘Improving the EU system for the
marketing authorisation of medicines’1 with regard to the use of
conditional marketing authorisation for oncology medicines.
1
http://escher.tipharma.com/fileadmin/media-archive/escher/Reports/Escher_report_IA.pdf
Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË - Tel. +32 22991111
xxxxxxxxxxxxxxxxxxxxxxxx@xx.xxxxxx.xx
b. Experience with conditional marketing authorisations (CMA), with
authorisation under exceptional circumstances and accelerate assessment-
European Medicines Agency
c. FDA Breakthrough therapy designation
d. Member States’ experience on results from the use of early access tools
(conditional marketing authorisation, authorisation under exceptional
circumstances, accelerated assessment) in terms of real time gains and
availability of medicinal products to patients: problems, opportunities and
lessons learnt.
7. Discussion and prioritisation of possibilities for more effective use of existing
early access regulatory tools –work plan for next meetings
* * *
2