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.
Overview of the activities of the STAMP expert Group in 2015 – 2016.
12th Meeting of the STAMP Expert Group on 29 January 2021
11th Meeting of the STAMP Expert Group on 15 March 2019 (Brussels)
- Agenda
- Presentations and background documents (following agenda items):
- 3. Repurposing of established medicines/active substances
- Background documents:
- Repurposing of established medicines/active substances - Agenda item 3
- Proposal for a framework to support not-for-profit organisations in drug repurposing
- Pilot of the STAMP repurposing pathway - Proposal of candidates by the Anticancer Fund
- Strengthening training of academia in regulatory sciences and supporting regulatory scientific advice (STARS)
- Presentation on proposal for a repurposing framework
- Presentation on repurposing pilot
- Background documents:
- 4. Presentations of OECD reports
- 3. Repurposing of established medicines/active substances
- Record
10th Meeting of the STAMP Expert Group on 3 December 2018 (Brussels)
- Agenda
- Presentations and background documents (following agenda items):
- 3. Repurposing of established medicines/active substances
- 4. Presentation by Infectious Diseases Data Observatory, UK
- 5. Presentation of the EU Coordination and Support Action - STARS: Strengthening training of academia in regulatory sciences & supporting regulatory scientific advice
- 6. EU activities relevant to timely patient access to innovative medicines
- Record
9th Meeting of the STAMP Expert Group on 8 June 2018 (Brussels)
- Agenda
-
Presentations and background documents (following agenda items):
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3 - Repurposing of established medicines/active substances
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4 - Activities related to real world data
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5 - Study report on the impact of pharmaceutical incentives on innovation, availability and accessibility of medicinal products
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6 - EU activities relevant to timely patient access to innovative medicines
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8th Meeting of the STAMP Expert Group on 8 December 2017 (Brussels)
- Agenda
- Presentations and background documents (following agenda items):
- 3 - EU activities relevant to timely patient access to innovative medicines
- 4 - Ad hoc Synergy Group
- 5 - Repurposing of established medicines/active substances
- 6 - Heads of Medicines Agency Subgroup on Timely Access
- Record
7th Meeting of the STAMP Expert Group on 27 June 2017 (Brussels)
- Agenda
- Presentations and background documents (following the Agenda points):
- 3 - Repurposing of established medicines/active substances
- 4 - United States 21st Century Cures Act
- 5 - Compassionate use
- 6 - PRIME (PRIority MEdicines) scheme – first year of experience
- Record.
6th Meeting of the STAMP Expert Group on 13-14 March 2017 (Brussels)
- Agenda
- Presentations and background documents (following the Agenda points):
- Repurposing of established medicines/active substances session
- 3 - Off-label use of medicinal products
- 4 - Activities of STAMP 2015 – 2016 and beyond
- 5 - Synergies with Health Technology Assessment (HTA) Network
- 7 - Adaptive pathways
- 8 - Conditional Marketing Authorisation
- 10 - Update on other EU initiatives relevant for timely patient access to innovative medicines – Presentation by the Commission services
- Record.
5th Meeting of the STAMP Expert Group on 28 June 2016 (Brussels)
- Agenda.
- Presentations and background documents (following the Agenda points):
- 3 - Repurposing of established medicines/active substances
- 4 - Off label use of medicinal products
- 5 - Health Technology Assessment (HTA) Network Reflection Paper on Regulatory and HTA issues
- 6 - Update on European Medicines Agency activities
- 7 - Council Conclusions on Strengthening the balance in the pharmaceutical system in the EU and its Member States
- Record.
4th Meeting of the STAMP Expert Group on 10 March 2016 (Brussels)
- Agenda.
- Presentations and background documents (following the Agenda points):
- 3 - Repurposing of established medicines/active substances
- 4 - Real world evidence data collection
- 5 - Update on European Medicines Agency activities
- 6 - Compassionate use programmes
- 7 - Personalised medicines
- Record.
3d Meeting of the STAMP Expert Group on 20 October 2015 (Brussels)
- Agenda.
- Presentations and background documents (following the Agenda points):
- 3 - Regulatory tools for early access:
- a. Conditional marketing authorisations (CMA)
- b. Accelerated assessment and PRIME scheme
- Revised CHMP guidelines and summary of comments received during public consultation.
- PRIME New scheme to support development of innovative medicines for unmet needs. Background document for discussion.
Public consultation started on 26 October with the deadline for comments 23 December 2015. Further information can be found on EMA website.
- c. Adaptive Pathways
- Comprehensive discussion on policy related issues on the basis of current experience from the EMA's pilot project.
- "Prescrire" presentation and position paper on adaptive pathways.
- d. Cross-cutting issues for all tools
- 4 - Update on other EU initiatives relevant for timely patient access to innovative medicines
- 3 - Regulatory tools for early access:
- Record.
2nd Meeting of the STAMP Expert Group on 6 May 2015 (Brussels)
- Agenda.
- Presentations (following the Agenda points):
- 3 - Regulatory tools for early access:
- 4 - Update on other EU initiatives relevant for timely patient access to innovative medicines:
- 5 - Exchange of experiences from national routes (other than clinical trials) for making available medicines to patients before authorisation: early access schemes, compassionate use etc.
- 6 - Introduction of Ministry of Health Labour and Welfare of Japan(MHLW)/Pharmaceuticals and Medical Devices Agency (PMDA) and recent updates in Japan
- Record.
1st Meeting of the STAMP Expert Group on 27 January 2015 (Brussels)
- Agenda.
- Presentations (following the Agenda points):
- 2. Scope and operation of the STAMP.
- 4. Exchange of experiences from national routes (other than clinical trials) for making available medicines to patients before authorisation:
- 5. EMA's pilot project on Adaptive Licensing.
- 6. Regulatory tools for early access
- a. Results from the Escher project 'Improving the EU system for the marketing authorisation of medicines'.
- b. FDA Breakthrough therapy designation program.
- c. Experience with conditional marketing authorisations (CMA).
- d. Member States' experience on results from the use of early access tools (conditional marketing authorisation, authorisation under exceptional circumstances, accelerated assessment).
- Record.