Transcript EDQM: Recent developments Dr Claude Coune Claude Coune
EDQM: Recent developments
Dr Claude Coune Head of the Publication and IT Department
EDQM = ?
• The D irectorate for the Q uality of M edicines of the Council of E urope • … & H ealth C are since 2007 • Built around the European Pharmacopoeia – By adding new activities related to the Quality of Medicine and having the European Pharmacopoeia as a basis – By adding new activities related to public health more generally.
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The Council of Europe
• 46 member states Claude Coune
The New Building
• Since the beginning of 2007, EDQM has moved into new premises – 15000 square meters of offices and laboratories – Modern facilities for the preparation and distribution of reference standards – In 1982, staff = 17; in 2007, staff = 165 Claude Coune
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A new director: Susanne Keitel
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Susanne Keitel
• Pharmacist, Ph. D. in pharmaceutical technology • 10 years in different positions at Schering A. G. (Germany) • Head of Division « Pharmaceuticak Quality » at the Bfarm, then Head of International Affairs • Vice-Chair of the Q.W.P. at EMeA • Chair of the German Pharmacopoeia Commission Claude Coune
EDQM today
• An intergovernmental organisation with 36 member states + E.U. and 19 Observer states + WHO • 165 people in Strasbourg • 500 experts throughout Europe • A network of over 80 control laboratories Claude Coune
The EDQM's Vision
• Our vision is to continue to be a leading organisation in the establishment of high quality standards for human and veterinary medicinal products as well as blood transfusion and organ transplantation recognised throughout Europe.
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EDQM’s mission
• Our mission is to contribute to the basic human right of access to good quality medicines and healthcare, and to promote and protect human and animal health by: – establishing and providing official standards for the manufacture and quality control of medicines applicable in all the signatory states of the Convention for the elaboration of a European Pharmacopoeia, – establishing standards for the quality control of blood transfusion and organ transplantation (tissues and cells) – setting up privileged collaboration with observer states at the European Pharmacopoeia Commission, and the Steering Committees for blood transfusion and organ transplantation (CD-P-TS and CD-P-TO) – organising a network of Official Medicines Control Laboratories to collaborate and share expertise.
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The European Union
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Ph. Eur. MEMBER & OBSERVERSHIP (including EU) Claude Coune
In the world
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Status of European Pharmacopoeia Observers
• Enables observers to participate in the scientific work of the Commission • To benefit from European experience • To gain access to work on the quality control of medicines and the methods of analysis used • The Commission may admit technically qualified observers to its sessions and Groups of Experts or Working Parties Claude Coune
European Pharmacopoeia Observers
• Can implement – Directly – Indirectly by translation and integration in their national pharmacopoeia • Part • Totally • Can use as scientific basis Claude Coune
Partnership CoE/EU
(2) European Authorities European Union European Union Council Parliament
Commission DG Entreprise Brussels
European Agency for the Evaluation of Medicinal Products
EMEA**** London
Council of Europe European Directorate for the Quality of Medicines & HealthCare Ph. Eur.** Certification*** *OMCL :Official Medicines Control Laboratories **Ph.Eur : European Pharmacopoeia ****EMEA : European Medicines Agency
EDQM Strasbourg
***Certification : Certification of Suitability of Monographs of the European Pharmacopoeia Claude Coune OMCL* Network
Relationship EDQM / EMEA
EDQM • Sends observers to EMEA • WG (quality, bio, immunological, herbal, inspectors…) • European Pharmacopoeia Commission and Group of Experts (blood, vaccines, viral safety and….) • Sends observers to • Biological Standardisation Programme (BSP) • Is member of Steering committees of EDQM Groups • European Pharmacopoeia, CEP (eg risk products, standard terms) • Requests • Include in its work programme • Implement for CCAP Signs contracts for Market surveillance of central authorised products (CAP) Claude Coune
European Pharmacopoeia
nearly 2,000 monographs; >1,900 reference standards
Chemicals dosage forms Fats
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Herbals Radiopharm.
Human vaccines Vet. Vaccines Plastics Blood deriv.
Antibiotics Gases homeopathy biologicals
Other activities (1)
• Certification of Suitability – The European Regulations require the applicant to demonstrate the quality of its products.
suitability of the Pharmacopoeia monograph to control the – EDQM created the CoS (or CEP) to help the manufacturers and the users in this respect – Recognised throughout Europe and in many other countries Claude Coune
Other activities (2)
• Network of Official Control Laboratories – Identify, training and audit • Aims for – Common rules, working & Quality Assurance standards – Mutual confidence and recognition of results • Active in the field of: – Establishment of Reference Standards – Market surveillance – Proficiency Testing Studies Claude Coune
Other activities (3)
• Pharmaceutical terminology – Standard terms for • Dose forms • Routes of administration • Containers – INN (WHO), ISO (for ICH) Claude Coune
New activities
• Guidelines on blood transfusion – Tests for donors – Tests for blood and blood fractions • Guidelines on Organ transplant • Dispensation conditions for medicinal products in Europe Claude Coune
CONCLUSION = 2007: a milestone
(1)
• Targets defined in 2004 achieved (symbolised by new building):
6th edition & its work programme Worksharing & international recognition (certification procedure, OMCLs, inspection and international various international stakeholder partnerships).
CONCLUSION = 2007: a milestone
(2) • A new start = to define the next tri-annual programme : Fostering collaboration, coordination, cooperation nationally / internationally In Europe/globally Between stakeholders sharing responsibility for Health authorities / industries Claude Coune
CONCLUSION = 2007: a milestone (3)
• Facing together new challenges: – diseases – counterfeit – Changes in climate and their consequences • In order to give more support and more efficiency to national and international actions and bodies (HMA, ICH, VICH, GCG, WHO, PDG….) Claude Coune
Conclusion (4) On the to do list
• Modernise general methods of analysis • Revise of old fashioned monographs • Add tests (and limits?) for functionality related characteristics (quality by design?) • Herbals: adapt to the new legislative framework + traditional medicines (China, India?), CoS?
• Homeopathy: CoS for mother tinctures?
• Create a training programme for interns from member and observer countries Claude Coune
Building a partnership for the investigation of counterfeit (1)
• • • • • • Facts: Counterfeits are a major public health concern Worldwide increased number of counterfeited medicines via legal or illegal distribution chains Europan Network of official medicines control laboratories owning appropriate skills/experience and equipments Industry associations and International Organization/Health Authorities established Task Forces devoted to develop concept/solutions to circonvain the issue Absence of harmonized legislation regarding the role of the different stakeholders (Health Authorities, police, customs, industries) Claude Coune
Building a partnership for the investigation of counterfeit
(2) • • • • • How to improve: Knowledge sharing: – Access to essential information (analytical methods, fingerprints, reference standards, authentic samples, packaging security systems, …) Work sharing: – Centers of expertise – Testing/Inspections (risk-based) – Improved communication system throughs secured databases – Ensure the integrity of each step of the supply chain Educational measures – Public policymakers/patients awareness (internet sales, safety) – Brokers/traders/wholesalers: parallel importation requires special attention Harmonization of legislation and strengthening of laws and enforcement Claude Coune