Pharmaceutical Committee working method and priorities
101st meeting of the Pharmaceutical Committee, 23 November 2023
Presentations
- Commission Communication on medicine shortages
- National security of supply measures
- National security of supply measures (background doc)
- JA on regulatory flexibilities, including magistral preparations
- JA to enhance or improve national stockpiling strategies
- Pharmacy preparations
- Pharmaceuticals in the Environment
100th meeting of the Pharmaceutical Committee, 21 October 2022
99th meeting of the Pharmaceutical Committee, 11 May 2022
- Agenda (pharm 836)
- Revision of the general pharmaceutical legislation (pharm 837) - Document for discussion
- Summary record (pharm 838)
98th meeting of the Pharmaceutical Committee, 20 January 2022
97th meeting of the Pharmaceutical Committee, 17 November 2021
Written procedure on the revision of the mandate of the ad-hoc Working Group on pharmaceuticals in the environment
96th meeting of the Pharmaceutical Committee, 17 September 2021
Documents
See also press release on the therapeutics strategy
Presentations
- Therapeutics strategy
- Titanium dioxide
- Pharmaceutical strategy
- Activities on security of supply
- Revision of the O/P framework
Joint meeting EU Directors for Pharmaceutical Policy & Pharmaceutical Committee, 8 and 9 July 2021
Documents
- Policy brief improving access to essential antibiotics
- Policy brief repurposing of medicines in oncology
Presentations
- HERA – State of play and interlink with antimicrobials
- Piloting innovative approaches to EU R&D and public procurement for antimicrobials; and on the outcome of the survey on the restriction and optimisation of antimicrobials usage
- EU-funded project: Ensure the availability of antibiotics in human and veterinary medicine while preserving the environment
- Improving access to essential antibiotics
- Repurposing of medicines – The hidden champion of sustainable innovation
- Repurposing drugs in oncology
- Framework to support not-for-profit organisations and academia (institutions and individuals) in drug repurposing by STAMP
- Presentation of the Policy brief: Repurposing of medicines in oncology
- Artificial intelligence for drug repurposing
94th meeting of the Pharmaceutical Committee, 28 May 2021
Documents
93rd meeting of the Pharmaceutical Committee, 17 and 22 February 2021
Documents
- Discussion of a work plan of the Committee on the revision of the general pharmaceutical acts (pharm 819)
- Revision of the orphan and paediatric medicines legislation (pharm 820)
92nd meeting of the Pharmaceutical Committee, 11 December 2020
Documents
- Revision of the orphan and paediatric medicines legislation (Pharm 815)
- Pharmaceutical strategy for Europe (Pharm 816)
91st extraordinary Pharmaceutical Committee – Brexit readiness, 17 November 2020
90th meeting of the Pharmaceutical Committee, 21 October 2020
Documents
89th meeting of the Pharmaceutical Committee, 18-21 September 2020
Documents
- Background note Pharma Strategy (Pharm 805)
- Document Pharm806 which relates to the point on BREXIT is not published for the moment as it relates to ongoing internal discussions and disclosure at this time would seriously undermine the decision making process. When its disclosure is possible, it will also be made available on this page.
88th meeting of the Pharmaceutical Committee, 2 July 2020
Documents
Presentations
- Evaluation of the legislation on medicines for children and rare diseases
- Update: pilot project ‘Market Launch Intentions of Centrally Authorised Products’
- Vaccine Strategy
87th meeting of the Pharmaceutical Committee, 26 May 2020
86th meeting of the Pharmaceutical Committee, 12 March 2020
Documents
- Evaluation of orphan & paediatrics regulations (Pharm 791)
- Study on medicines shortages (Pharm 792)
- COVID-19 (Pharm 793)
- Market launch of Centrally Authorised Products (Pharm 794)
- EU dependency on APIs (Pharm 795)
- Pharmaceuticals in the environment (Pharm 796)
85th meeting of the Pharmaceutical Committee, 17 December 2019
Documents
- Working methods and priorities (Pharm 783)
- Evaluation of orphan & paediatrics regulations (Pharm 785)
- Development of antimicrobials: how to address market failures (Pharm 786)
- Pharmaceuticals in the environment (Pharm 787)
- Quality of active pharmaceutical ingredients (Pharm 788)
84th meeting of the Pharmaceutical Committee, 7 November 2019
Documents
- Pharmaceutical Committee: mapping policy needs and working method (Pharm 777)
- Pharmaceuticals in the environment (Pharm 778)
- Anti-Microbial Resistance (Pharm 779a & 779b)
- Duplicate marketing authorisations for biological medicinal products (Pharm 780)
- Market launch of centrally authorised products (Pharm 781b)
- Document Pharm781a, please refer to Pharm 794 (meeting of 12 March 2020)
Presentations
83rd meeting of the Pharmaceutical Committee, 11 July 2019
Documents
- Pharmaceutical legislation: Challenges and opportunities - Scenario based brainstorming discussion (pharm769)
- Guidelines on GCP for ATMPs (pharm772)
- Guidelines on GCP for ATMPs (pharm772 annex)
- STAMP - Proposal for a framework for the repurposing of established medicines (pharm773)
- STAMP - Proposal for a framework for the repurposing of established medicines (pharm773 annex)
- Survey on the therapeutic use of bacteriophages (pharm 774)
Documents Pharm770 and Pharm771 are not published for the moment as they relate to ongoing internal discussions and disclosure at this time would seriously undermine the decision making process. When their disclosure is possible, they will also be made available on this page.
Presentations
- Feedback from conference ‘Medicines for rare diseases and children: learning from the past, looking to the future’
- STAMP – Repurposing of medicines
82nd meeting of the Pharmaceutical Committee, 01 April 2019
Invitation
Documents
- Modus operandi of the Pharmaceutical Committee, lessons learnt from the STAMP and update on its activities (pharm762)
- Innovation and access from the regulatory and competition enforcement perspectives (pharm765)
Presentations
- Pharmaceutical Committee, modus operandi, STAMP and update on its activities, DG SANTE, European Commission
- Repurposing of medicines - European Commission Expert Group on Safe and Timely Access to Medicines for Patients (STAMP)
- Report on Competition enforcement in the pharmaceutical sector, DG Competition, European Commission
81st meeting of the Pharmaceutical Committee, 23 October 2018
24/01/2019
15/11/2018
- Invitation
- Annex to the Invitation
- Agenda
- pharm760 – Summary record
- Documents
- pharm752_4i Shortages of medicinal products
- pharm753_3iii Evaluation of the EU legislation on blood, tissues and cells
- pharm753_3iii_annex Summary of Responses to the Open Public Consultation for the Evaluation of the Blood, Tissues and Cells Legislation
- pharm754_3i Evaluation of the Orphan and Paediatric Regulations
- pharm755_2ii Overview of Member States biennial reports on audits of their pharmacovigilance systems (2017 reporting year)
- pharm756_ 3iv Study on the experience acquired as a result of the procedures for authorisation and monitoring of medicinal products for human use
- pharm757_3ii Commission Report on Product Information Leaflets and related activities
- pharm758_1i Update on Court cases
- pharm759_4iv Duplicate marketing authorisation applications of biological medicinal products
- pharm759_4iv_annex Targeted stakeholder consultation on duplicate marketing authorisations for biological medicinal products consultation document
- Presentations
- pharm_2i European Commission Expert Group on Safe and Timely Access to Medicines for Patients (STAMP)
- pharm_3i Evaluation of EU Orphan and Paediatric Regulations
- pharm_3ii Follow-up to Commission's Report on Product Information Leaflets and related activities
- pharm_3iii Evaluation of the EU legislation on Blood, Tissues and Cells
- pharm_4ii Questionnaire on health and safety preventive and protective measures for workers handling cytotoxic pharmaceuticals
- pharm_4iv Duplicate marketing authorisation applications: The case of duplicates of biological medicinal products
- pharma_3iv Study on MA procedures
80th meeting of the Pharmaceutical Committee, 8 March 2018
25/06/2018
16/03/2018
- Invitation
- Annex invitation
- Agenda
- Documents
- pharm744_2i Falsified Medicines Directive – Update on the implementation of the safety features (medicine serialisation)
- pharm745_4i Introduction to the Commission Proposal for a Regulation on Health Technology Assessment (HTA) amending Directive 2011/24/EU
- pharm746_3i Update on the state-of-play of the evaluation of the orphan and paediatric regulations
- pharm747_3iv Shortage of medicines
- pharm748_1i Update on Court cases
- pharm749_1ii Legal and Regulatory news
- pharm750_4iii Questionnaire – health and safety preventive and protective measures for the workers in a healthcare area while handling cytotoxic pharmaceuticals
- Presentations
- pharm_2iii European Commission Expert Group on Safe and Timely Access to Medicines for Patients (STAMP)
- pharm_3ii EMA action plan related to the European Commission’s recommendations on product information - Update on ongoing activities
- pharm_3ii Commission Report on Product Information Leaflets
- pharm_4i Proposal for a Regulation of the European Parliament and of the council on health technology assessment and amending Directive 2011/24/EU
79th meeting of the Pharmaceutical Committee, 27 October 2017
11/01/2018
21/11/2017
- Invitation
- Annex invitation
- Agenda
- Documents
- pharm734_2iii Feedback from the Commission Expert Group on Safe and Timely Access to Medicines for Patients (STAMP)
- pharm735_2iv Report on use of additional monitoring list
- pharm736_3v Shortage of medicines: Questionnaire on measures implemented in the Member States territories in the context of Article 81 of Directive 2001/83/EC
- pharm737_2i Falsified Medicines Directive – Update on the implementation of the safety features (medicine traceability)
- pharm738_1i Update on Court cases
- pharm739_1ii Legal and Regulatory news
- pharm740_3ii Commission's Report on Product Information Leaflets and related activities (EMA Action Plan)
- pharm741_2ii Draft Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products
- Presentations
- pharm_2ii Good Manufacturing Practice for ATMPs
- pharm_2iii Update on the European Commission Expert Group on Safe and Timely Access to Medicines for Patients (STAMP)
- pharm2_iv Analysis on the experience with additional monitoring
- pharm_3i The 2017 Paediatric Report and the evaluation of orphan and paediatrics legislation
- pharm_3ii EMA Action Plan related to the European Commission’s recommendations on product information
- pharm_3ii Commission Report on Product Information Leaflets
- pharm_3iii Planned study on marketing authorisation procedures
- pharm_5i The "Yellow Hand" symbol
78th meeting of the Pharmaceutical Committee, 27 March 2017
30/05/2017
07/04/2017
- Invitation
- Annex invitation
- Agenda
- Documents
- pharm726_1i Update on Court cases
- pharm727_1ii Legal and Regulatory news
- pharm728_2ii Report on activity of the Expert Group on Safe and Timely Access to Medicine for Patients (STAMP) 2015 - 2016
- Pharm728_2ii STAMP activity report (REPORT)
- pharm729_3ii Report on use of additional monitoring list – experience of Member States
- pharm730_6ii Shortage of medicines
- pharm731_2ib Guidelines on Good Manufacturing Practice for Advanced Therapy Medicinal Products
- Presentations
- pharm_2ia Initiatives on ATMPs
- pharm_2ib Good Manufacturing Practice for ATMPs
- pharm_2ii Update on the European Commission Expert Group on Safe and Timely Access to Medicines for Patients (STAMP)
- pharm_3i Update on SCOPE - Strengthening Collaborations to Operate Pharmacovigilance in Europe
- pharm_3ii Report on use of additional monitoring list - experience of Member States
- pharm_4iii Assessment report under article 59(4) of Directive 2001/83/EC on the current shortcomings in the SmPC and PL
- pharm_6i EU cooperation on HTA
77th meeting of the Pharmaceutical Committee, 18 October 2016
08/12/2016
20/10/2016
- Invitation
- Annex Invitation
- Agenda
- Documents
- pharm716_1i Update on Court cases
- pharm717_1ii Legal and Regulatory news
- pharm718_4i Paediatrics
- pharm719_6i Strengthening of the EU cooperation on Health Technology Assessment (HTA)
- pharm720_2iii Implementation of the "Falsified Medicines Directive" – Update on the common logo for online pharmacies
- pharm721_2ii Implementation of the Clinical Trials Regulation
- pharm722_3i Report from the Commission on pharmacovigilance related activities
- pharm723_3ii Overview of Member States biennial reports on audits of their pharmacovigilance systems (2015 reporting year)
- Presentations
- pharm_2iv Update on the European Commission expert group on Safe and Timely Access to Medicines for Patients (STAMP)
- pharm_2v Council Conclusions on strengthening the balance in the pharmaceutical systems in the European Union and its Member States
- pharm_3i 3-year Report on European Union Pharmacovigilance Activities
- pharm_4i Commission report on the Paediatric Regulation
- pharm_6i Initiative on Strengthening EU Cooperation on Health Technology Assessment (HTA)
76th meeting of the Pharmaceutical Committee, 28 April 2016
08/06/2016
02/05/2016
- Invitation
- Annex Invitation
- Agenda
- Documents
- pharm703_2ii Orphan medicinal products
- pharm703_2ii (Annex 1) Commission notice on the application of articles 3, 5 and 7 of Regulation (ec) no 141/2000 on orphan medicinal products
- pharm704_2i Good Manufacturing Practice for ATMPs
- pharm705_2iii Implementation of the Clinical Trial Regulation
- pharm706_2iv Implementation of the "Falsified Medicines Directive" 2011/62/EU
- pharm707_1i Update on Court cases
- pharm708_1ii Legal and Regulatory news
- pharm709_4i Paediatrics
- pharm710_5ai A Reformed ICH: Better Equipped for Global Harmonisation and Regulation of Technical Requirements for Medicines
- pharm712_2v Update on the European Commission expert group on Safe and Timely Access to Medicines for Patients (STAMP)
- pharm713_5bii Agreements on Conformity Assessment and Acceptance of industrial products (ACAA)
75th meeting of the Pharmaceutical Committee, 21 October 2015
22/12/2015
03/11/2015
- Invitation
- Annex Invitation
- Agenda
- Documents
- pharm689_2b Revision of the 2003 Communication on orphan medicinal product
- pharm690_1a Court cases
- pharm691_1b Legal and regulatory news
- pharm692_1c Variations and the use of the Article 57 database
- pharm693_3b Overview of Member States biennial reports on audits of their pharmacovigilance systems (2013 reporting year)
- pharm694_4a Paediatrics: "Road to 2017"
- pharm695_2f Implementation of the "Falsified Medicines Directive" 2011/62/EU
- pharm696_2e Clinical Trials Regulation: update on the implementation
- pharm697_6b WHO Biological Qualifier
- pharm698_2d Feedback from the 2nd meeting of the Commission Expert Group on "Safe and Timely Access to Medicines for Patients"
- pharm699_6a Summary of comments to the study report on the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC)
- pharm700_5b International developments – Update on bilateral negotiations: TTIP – Preparation of technical paper on generics
- Presentations
- Reports
- Study on the Package Leaflets and the Summaries of Product Characteristics of Medicinal Products for Human use (PIL-S study)
- Feasibility and value of a possible “key information section” in patient information leaflets and summaries of product characteristics of medicinal products for human use (The PILS-BOX study)
74th meeting of the Pharmaceutical Committee, 17 March 2015
- Invitation
- Annex Invitation
- Agenda
- Pharm678_CourtCases
- Pharm679_LegalRegulatory
- Pharm680_STAMP
- Pharm681_Regulation on clinical trials – update on implementation
- Pharm682_Falsified (implementation)
- Pharm683_Logo
- Pharm684_Orphans
- Pharm685_Joint procurement for medical counter measures
- Pharm686_ICH reform
- Presentation on Registries – point 1 d
- Presentation on Forthcoming activities on Orphans – point 2 f
- Presentation on ICH- point 4 a
- Presentation on TTIP – point 4 b
- Presentation on Joint Procurement – point AOB a
- Presentation on 50 years of EU legislation – point AOB b
73nd meeting of the Pharmaceutical Committee, 22 October 2014
26/01/2015
24/11/2014
- External Study Report on the Availability of Medicinal Products for Human Use
- Summary of comments
- Comments of members and observers of the Pharmaceutical Committee
- Comments of Heads of Medicines Agencies Management Group
24/10/2014
- Invitation
- Annex Invitation
- Agenda
- Pharm661 Court Cases
- Pharm662 Legal Regulatory News
- Pharm663 50 years
- Pharm664 Paediatric
- Pharm 665 Biological Qualifier
- Pharm 666 AMR
- Pharm 666 Commission s reply to Consultation
- Pharm 667 VetMed
- Pharm 668 Clinical Trial Regulation COMM update
- Pharm 669 Clinical Trial Regulation EMA update
- Pharm 670 Availability study
- Pharm 671 Regulatory framework and early access
- Pharm 672 Regulatory framework and early access Annex
- Pharm 672 RIVM report Minds Open-Sustainability of the European regulatory system
- Pharm 673 Logo
- Pharm 674 Pharmacovigilance
- Pharm 675 Water pollution
72nd meeting of the Pharmaceutical Committee, 26 March 2014
03/07/2014
05/05/2014
- Invitation
- Agenda
- Pharm641 CourtCases
- Pharm642 AccessMedicines
- Pharm643 50 years
- Pharm644 Falsified
- Pharm645 GMP guide
- Pharm646 Chapter6
- Pharm647 GMP Chapter2 revision
- Pharm648 PAES
- Pharm649 Pediatrics
- Pharm650 IPRF
- Pharm651 IPRF Tor
- Pharm652 IPRF Draft Meeting report
- Pharm653 IPRF Public Statement
- Pharm654 INN Biosimilars
- Pharm655 Study off label use
- Pharm656 Identification Biological
- Pharm657 Clinical trials update
- Pharm658 Transatlantic Trade and Investment Partnership
71st meeting of the Pharmaceutical Committee, 23 October 2013
12/02/2014
30/10/2013
- Invitation
- Annex invitation
- Pharm626 Agenda
- Pharm627 Paediatrics
- Pharm628 CourtCases
- Pharm629 Orphacol
- Pharm630 Traceability Biologicals
- Pharm631 Legal Regulatory
- Pharm632 API Imports
- Pharm633 Falsified Implementation
- Pharm634 AMR
- Pharm635 IPRF
- Pharm636 Pharmacovigilance
- Pharm637 Kava
- Pharm638 OrganicOrigin
70th meeting of the Pharmaceutical Committee, 27 March 2013
06/06/2013
02/04/2013
- Invitation
- Annex invitation
- Pharm615 Agenda
- Pharm616 Personalised medicine
- Pharm617 Delegated act
- Pharm618 Legal Regulatory
- Pharm619 Enforcement Pharmacovigilance
- Pharm620 Court Cases
- Pharm621 International Devel
- Pharm622 API import
- Pharm623 Implementation
- Pharm624 Classification
69th meeting of the Pharmaceutical Committee, 22 October 2012
19/12/2012
- Invitation
- Pharm607 Agenda
- Pharm608 Advanced Therapy Medicinal Products (ATMPs)
- Pharm609 Legal Regulatory
- Pharm610 Shortages of medicinal products
- Pharm611 Enforcement Pharmacovigilance
- Pharm612 Interpretation of Pharmaceutical legislation – ECJ
- Pharm613 Active Product Ingredients Imports
68th meeting of the Pharmaceutical Committee, 28 March 2012
08/10/2012
- Invitation
- Pharm599 Agenda
- Pharm600 Hospital exemption for ATMPs
- Pharm601 Pharmacovigilance legislation
- Pharm602 Falsified medicines
- Pharm603 Paediatric Regulation
- Pharm604 Interpretation of Pharmaceutical legislation – ECJ
- Pharm605 Interpretation of the legislation on biosimilars
1997 - 2011 meetings
01/03/2012
Pharmaceutical Committee - Summary record of the 67th meeting, 5 October 2011
18/10/2011
Pharmaceutical Committee - Meeting Report of the 67th meeting, 5 October 2011
29/07/2011
Pharmaceutical Committee - Summary record of the 66th meeting, 14 February 2011
14/02/2011
Pharmaceutical Committee - Meeting Report of the 66th meeting, 14 February 2011
30/03/2009
Pharmaceutical Committee - Meeting Report of the 65th meeting, 16 March 2009
16/03/2009
Pharmaceutical Committee - Summary record of the 65th Pharmaceutical Committee
18/04/2008
Pharmaceutical Committee - Summary record of the 63rd meeting, 10 December 2007
19/12/2007
Pharmaceutical Committee - Meeting Report of the 63rd meeting, 10 December 2007
31/07/2007
Pharmaceutical Committee - Summary record of the 62nd meeting, 21 May 2007
29/05/2007
Pharmaceutical Committee - Meeting Report of the 62nd meeting, 21 May 2007
05/03/2007
Pharmaceutical Committee - Summary record of the 61st meeting, 5 December 2006
11/12/2006
Pharmaceutical Committee - Meeting Report of the 61st meeting, 5 December 2006
11/07/2006
Pharmaceutical Committee - Summary record of the 60th meeting, 2 May 2006
23/02/2006
Pharmaceutical Committee - Summary record of the 59th meeting, 2 December 2005
10/10/2005
Pharmaceutical Committee - Summary record of the 58th meeting, 1 June 2005
26/04/2005
Pharmaceutical Committee - Summary record of the 57th meeting, 8-9 November 2004
09/09/2004
Pharmaceutical Committee - Summary record of the 56th meeting 19 January 2004
09/09/2004
Pharmaceutical Committee - Summary record of the 55th meeting 15 May 2003
20/06/2003
Pharmaceutical Committee - Information on the outcome of the 54th meeting 13th November 2002
20/06/2003
Pharmaceutical Committee - Information on the outcome of the 53rd meeting 14th May 2002
11/04/2002
Pharmaceutical Committee - Information on the outcome of the 52nd meeting (16 Nov 2002)
18/11/2001
Pharmaceutical Committee - Information on the outcome of the 51st meeting (5 April 2001)
23/11/2000
Pharmaceutical Committee - Information on the outcome of the 50th meeting (21-22 September 2000)
15/05/2000
Pharmaceutical Committee - Information on the outcome of the 49th meeting
Related documents: PHARM 285, PHARM 287, PHARM 289, PHARM 293, PHARM 293a, PHARM 295, PHARM 296, PHARM 298, PHARM 300, PHARM 304.
27/09/1999
Pharmaceutical Committee - Information on the outcome of the 48th meeting
Related documents: PHARM 263, PHARM 264, PHARM 266, PHARM 268, PHARM 272, PHARM 273, PHARM 274, PHARM 275, PHARM 276.
11/05/1999
Pharmaceutical Committee - Information on the outcome of the 47th meeting (15-16 April 1999)
26/03/1998
Pharmaceutical Committee - Information on the outcome of the 45th meeting (16 March 1998)
17/09/1997
Pharmaceutical Committee - Information on the outcome of the 44th meeting (16-17 September 1997)
11/06/1997
Pharmaceutical Committee - Information on the outcome of the 43rd meeting (11 June 1997)
11/06/1997
Pharmaceutical Committee - Information on the outcome of the 42nd meeting (20 February 1997)
