Dies ist eine HTML Version eines Anhanges der Informationsfreiheitsanfrage 'Information on expert group STAMP'.




 
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 
 
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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 
 
 
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